background image

•  Scaffold retrieval methods (use of additional wires, snares, and / or forceps) may 

result in additional trauma to the coronary vasculature and / or the vascular access 

site. Complications may include bleeding, hematoma, or pseudoaneurysm.

•  When multiple Absorb GT1 Bioresorbable Vascular Scaffolds and drug-eluting stents 

are required, only Absorb GT1 Bioresorbable Vascular Scaffolds, Absorb Bioresorbable 

Vascular Scaffolds or everolimus-eluting stents must be used. Potential interaction 

with other drug-eluting stents or coated stents has not been evaluated and should 

be avoided.

•  The extent of the patient’s exposure to drug and polymer is directly related to the 

number of scaffolds implanted. A patient can receive up to a total scaffolding length 

of 94 mm.

•  The safety and effectiveness of the Absorb GT1 BVS in patients with prior 

brachytherapy of the target lesion or the use of brachytherapy for treated site 

restenosis in an Absorb GT1 BVS have not been established. Both vascular 

brachytherapy and the Absorb GT1 BVS alter arterial remodeling. The combination 

between these two treatments has not been established.

• 

Postdilatation with a noncompliant balloon is recommended

 following instructions in 

section 

10.7 Further Expansion of the Deployed Scaffold,

 as long as the postdilated 

segment is within the allowable expansion limits of the scaffold.

•  An unexpanded scaffold may be retracted into the guiding catheter 

one time only.

 An 

unexpanded scaffold should not be reintroduced into the artery once it has been pulled 

back into the guiding catheter. Subsequent movement in and out through the distal end 

of the guiding catheter should not be performed, as the scaffold may be damaged or 

dislodged during retraction back into the guiding catheter.

•  Should resistance be felt at any time during removal of the undeployed Absorb GT1 

BVS System, please refer to the steps provided in section 

6.4 Scaffold / System 

Removal – Precautions.

•  In the rare event of acute occlusion following scaffold placement, a bailout implant 

may be inserted and deployed within the scaffold such that the Absorb GT1 BVS is 

completely covered by the bailout implant. All abrupt closures must be treated as an 

emergency per the hospital standard of care.

Note:

 It is recommended that bailouts be done with a metallic everolimus-eluting stent 

of appropriate size. 

6.3 

Use in Conjunction with Other Procedures

•  While vessel preparation in complex lesions may include the use of various mechanical 

atherectomy devices, the safety and effectiveness have not been formally established 

in clinical trials with use of either mechanical atherectomy devices (directional 

atherectomy catheters, rotational atherectomy catheters) or laser angioplasty catheters 

in conjunction with Absorb GT1 BVS implantation. 

6.4 

Scaffold / System Removal – Precautions

•  Scaffold delivery system removal prior to scaffold deployment

If removal of a scaffold system is required prior to deployment, ensure that the guide 

catheter is coaxially positioned relative to the scaffold delivery system and cautiously 

withdraw the scaffold delivery system into the guiding catheter. Should 

unusual 

resistance

 be felt 

at any time

 when withdrawing the scaffold into the guide catheter, 

the scaffold delivery system and the guide catheter should be 

removed as a single 

unit. 

This should be done under direct visualization with fluoroscopy.

•  Withdrawal of the scaffold delivery system / postdilatation balloon from the deployed 

scaffold

1.  Deflate the balloon by pulling negative on the inflation device. Larger and longer 

balloons will take more time (up to 30 seconds) to deflate than smaller and 

shorter balloons. Confirm balloon deflation under fluoroscopy.

2.  Position the inflation device to “negative” or “neutral” pressure.

3.  Stabilize guide catheter position just outside coronary ostium and anchor in place. 

Maintain guide wire placement across scaffold segment.

4.  Gently remove the scaffold delivery system with slow and steady pressure.

5.  Tighten the rotating hemostatic valve.

Notes: 

1) 

If, during withdrawal of the catheter from the deployed scaffold, resistance is 

encountered, use the following steps to improve balloon rewrap:

 

°

Re-inflate the balloon up to nominal pressure, deflate and change pressure 

to neutral.

 

°

Repeat steps 1 through 5 above.

2)  After successful withdrawal of the balloon from the deployed scaffold, should 

any resistance be felt 

at any time

 when withdrawing the scaffold delivery system 

or postdilatation balloon into the guide catheter, 

remove the entire system as a 

single unit.

•  Failure to follow these steps and / or applying excessive force to the delivery system 

can potentially result in loss or damage to the scaffold and / or delivery system 

components.

•  If it is necessary to retain guide wire position for subsequent artery / lesion access, 

leave the guide wire in place and remove all other system components.

6.5 

Post Implant – Precautions

• 

If necessary to cross a newly deployed scaffold

 with a guide wire, balloon, delivery 

system, or imaging catheters, exercise care to avoid disrupting the scaffold geometry. 

•  Antiplatelet therapy should be administered post-procedure (see section 

9.1 

Individualization of Treatment

).

6.6 

MRI Statement

Comparison to the XIENCE PRIME metallic stents* indicates that the Absorb GT1 BVS is MR 

Conditional and can be scanned safely under the following conditions:

•  Static magnetic field of 3 Tesla or less

•  Spatial gradient of 2500 Gauss/cm or less

•  Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal 

operating mode) for up to 15 minutes of scanning for each sequence

The Absorb GT1 BVS should not migrate in this MRI environment, nor should there be safety 

concerns related to scaffold or marker heating. No concerns related to the effect of the 

above MRI environment on the drug content or drug release rate are anticipated. Due to its 

material properties, the same MR condition restrictions appropriate for the XIENCE PRIME 

stent apply more conservatively to the Absorb GT1 BVS. It is unknown if MR image quality 

will be compromised if the area of interest is in the exact same area or relatively close to the 

position of the Absorb GT1 BVS.

*Nonclinical testing was completed on XIENCE PRIME units in single and in overlapped 

configurations up to 71 mm in length and is on file with Abbott Vascular.

6.7 

Drug Interactions

Everolimus is extensively metabolized by the cytochrome P4503A4 (CYP3A4) in the gut 

wall and liver, and is a substrate for the countertransporter P-glycoprotein. Everolimus has 

also been shown to reduce the clearance of some prescription medications when it was 

administered orally along with cyclosporine (CsA). Hence, everolimus, when prescribed as 

an oral medication, may interact with other medications that include (but are not restricted 

to) inhibitors and inducers of CYP3A4 isozymes; absorption and subsequent elimination of 

everolimus may be influenced by drugs that affect these pathways. Formal drug interaction 

studies have not been performed with the Absorb GT1 BVS System. Therefore, due 

consideration should be given to the potential for both systemic and local drug interactions in 

the vessel wall, when deciding to place the Absorb GT1 BVS in a subject taking a drug with 

known interaction with everolimus.

Everolimus, when prescribed as an oral medication, may interact with some drugs or  

foods

1,2,3,4,5

 including, but not limited to:

•  CYP3A4 / PgP inhibitors that may increase everolimus blood concentrations:

 

°

Immunosuppressant cyclosporine 

 

°

Antifungal agents (e.g., fluconazole, ketoconazole, itraconazole ketoconazole)

 

°

Macrolide antibiotics (e.g., clarithromycin, erythromycin) 

 

°

Calcium channel blockers (e.g., verapamil, nicardipine, diltiazem) 

 

°

Protease inhibitors (e.g., nelfinavir, indinavir, amprenavir) 

 

°

Other substances (e.g., cisapride, metoclopramide, bromocriptine, cimetidine, 

danazol)

•  CYP3A4 inducers that may decrease everolimus drug concentrations:

 

°

Antibiotics (e.g., rifampin, rifabutin)

 

°

Anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin)

 

°

Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, nevirapine)

 

°

Glucocorticoids (e.g., dexamethasone, prednisone, prednisolone)

 

°

HMGCoA reductase inhibitors (e.g., simvastatin, lovastatin)

 

°

Other (e.g., St. John’s Wort)

For more detailed drug interaction information, please reference the most recent everolimus 

drug label 

1, 2, 3 ,4, 5

.

6.8 Pregnancy

This product (the Absorb GT1 BVS System) and everolimus have not been tested in pregnant 

or nursing women or in men intending to father children. Effects on the developing fetus have 

not been studied. While there is no contraindication, the risks and reproductive effects are 

unknown at this time. 

7.0 

ADVERSE EVENTS

7.1 

Observed Adverse Events

Adverse events observed in the ABSORB clinical trials that are related to the key clinical 

outcomes of death, cardiac death, myocardial infarction (MI)(Q-wave and non-Q-wave), 

target lesion revascularization (TLR) (by percutaneous coronary intervention [PCI] or 

coronary artery bypass graft), scaffold thrombosis, and ischemia-driven Major Adverse 

Cardiac Event (MACE) (composite of cardiac death, MI, ischemia-driven TLR [ID-TLR]) are 

presented in section 

8.0 Clinical Investigations of Absorb BVS System.

 All other adverse 

events are included in section 

7.2 Potential Adverse Events.

 

7.2 

Potential Adverse Events

Adverse events that may be associated with PCI, treatment procedures, and the use of a 

coronary scaffold in native coronary arteries include the following, but are not limited to:

•  Abrupt closure 

•  Access site complications 

•  Allergic reaction or hypersensitivity 

to contrast agent or polymer poly 

(L-lactide) (PLLA), polymer poly (D,L-

lactide) (PDLLA), and drug reactions to 

antiplatelet drugs or contrast agent 

•  Aneurysm 

•  Arrhythmias, including atrial and 

ventricular 

•  Arterial perforation 

•  Arterial rupture 

•  Arteriovenous fistula 

•  Bleeding complications, which may 

require transfusion 

•  Cardiac arrest

•  Cardiac, pulmonary, or renal failure

•  Cardiac tamponade

•  Coronary artery spasm 

•  Coronary or scaffold embolism 

•  Coronary or scaffold thrombosis 

•  Death 

•  Dissection of the coronary artery

•  Distal emboli (air, tissue, or thrombotic)

•  Emergent or non-emergent surgery

•  Fever

•  Hypotension / hypertension

•  Infection and pain

•  Injury to the coronary artery

•  Ischemia, myocardial

•  Myocardial infarction 

•  Nausea and vomiting

•  Palpitations

•  Pericardial effusion

•  Pericarditis

•  Peripheral ischemia (due to vascular 

injury)

•  Peripheral nerve injury

•  Pulmonary edema

•  Pseudoaneurysm

•  Renal insufficiency / failure

•  Restenosis of scaffolded segment

•  Shock

•  Stroke / cerebrovascular accident 

and TIA

•  Total occlusion of coronary artery

•  Unstable or stable angina pectoris

•  Vascular complications, including entry 

site, which may require vessel repair

•  Ventricular arrhythmias, including 

ventricular fibrillation and ventricular 

tachycardia

•  Vessel dissection

Adverse events associated with daily oral administration of everolimus in doses varying 

from 1.5 mg to 10 mg daily can be found in the Summary of Product Characteristics (SPC) 

and labels for the drug 

1,2,3,4,5

. The risks described below include the anticipated adverse 

events relevant for the cardiac population referenced in the contra-indications, warnings and 

precaution sections of the everolimus labels / SPCs and/or observed at incidences ≥ 10% in 

clinical trials with oral everolimus for different indications. Please refer to the drug SPCs and 

labels 

1,2,3,4,5 

for more detailed information and less frequent adverse events. 

•  Abdominal pain 

•  Anemia 

•  Angioedema

•  Arterial thrombotic events

•  Bleeding and coagulopathy (including 

Hemolytic uremic syndrome, thrombotic 

thrombocytopenic purpura and 

thrombotic microangiopathy)

•  Constipation

•  Cough

•  Diabetes mellitus

•  Diarrhea

•  Dyspnea

•  Embryo-fetal toxicity

•  Headache 

•  Hepatic artery thrombosis

•  Hepatic disorders (including hepatitis 

and jaundice)

•  Hypersensitivity to everolimus active 

substance, to other rapamycin derivates

1

 Certican

®

 UK label Nov 2014

2

 Afinitor

®

 EU authorization SPC Dec 2014

3

 Votubia

®

 EU SPC Sept 2014

4

 Afinitor

®

 US label Dec 2014

5

 Zortress

®

 US label Feb 2013

Refer to www.MHRA.gov.uk, www.ema.europa.eu, and www.fda.gov for the most recent 

versions of these SPC/labels.

•  Hypertension 

•  Infection (bacterial, fungal, viral or 

protozoan infections, including infections 

with opportunistic pathogens. Polyoma 

virus-associated nephropathy (PVAN), 

JC virus associated progressive 

multiple leukoencephalopathy (PML), 

fatal infections and sepsis have been 

reported in patients treated with oral 

everolimus) 

•  Kidney arterial and venous thrombosis

•  Laboratory test alterations 

(elevations of serum creatinine, 

proteinuria, hypokalemia; 

hyperglycemia, dyslipidemia 

including hypercholesterolemia and 

hypertriglyceridemia; liver function tests 

abnormal; decreases in hemoglobin, 

lymphocytes, neutrophils, and platelets)

•  Lymphoma and skin cancer

•  Male infertility

•  Nausea

•  Nephrotoxicity (in combination with 

cyclosporine)

•  Non-infectious pneumonitis (including 

interstitial lung disease) 

•  Oral ulcerations

•  Pain 

•  Pancreatitis

•  Pericardial effusion

•  Peripheral oedema

•  Pleural effusion

•  Pneumonia 

•  Pyrexia

•  Rash 

•  Renal failure

•  Upper respiratory tract infection

•  Urinary tract infection

•  Venous thromboembolism

•  Vomiting

•  Wound healing complications (including 

wound infections and lymphocele) 

8.0  

CLINICAL INVESTIGATIONS OF ABSORB BVS SySTEM

The Absorb GT1 BVS is based on the predicate device, Absorb BVS. The clinical 

investigations outlined in section 

8.0

 were performed on the Absorb BVS.

The Absorb GT1 BVS has the same mode of expansion, backbone material, scaffold coating, 

drug density, permanent scaffold markers, and scaffold design as the Absorb BVS. The 

Absorb GT1 BVS differs from the Absorb BVS only in the scaffold delivery system. The 

Absorb GT1 scaffold delivery system utilizes the same principle of operation and materials as 

other Abbott Vascular RX stent / scaffold systems and coronary dilatation catheters. 

Based on the identical nature of the Absorb GT1 scaffold to the Absorb scaffold, 

performance of the Absorb GT1 BVS can be predicted to be similar to the performance of 

Absorb BVS. Therefore, clinical trial data for Absorb BVS are summarized in this section.

8.1 

ABSORB Clinical Trial

The ABSORB clinical investigation is a prospective, single-arm, open-label, multicenter, 

international clinical study to evaluate safety and performance of the Absorb BVS in coronary 

arteries. The study was designed to enroll up to 30 patients (Cohort A) at 4 clinical sites 

followed by approximately 101 patients (Cohort B) at 12 clinical sites in Europe and Asia 

Pacific region.

Eligible Criteria:

 Patients at least 18 years of age with evidence of angina, myocardial 

ischemia, or a positive functional test; female patients with childbearing potential with 

a negative pregnancy test within 7 days prior to the index procedure and effective 

contraception during participation in this clinical investigation; and patients who signed 

an informed consent prior to enrollment. Angiographic inclusion criteria included: Nominal 

vessel diameter of 3.0 mm; lesion length ≤ 8 mm by visual estimation extended to ≤ 14 mm 

for the 3.0 x 18 mm scaffold; % diameter stenosis (%DS) of ≥ 50% and < 100%; TIMI flow 

of ≥ 1. Key angiographic exclusion criteria included: aorto-ostial location; left main location 

within 2 mm of the origin of the LAD or LCX; excessive tortuosity proximal to or within the 

lesion; extreme angulation (≥ 90°); heavy calcification; restenotic from previous intervention; 

target vessel containing thrombus; other clinically significant lesions in the target vessel or 

side branch.

Treatment Strategy:

 Predilatation of the target lesion was mandatory. Planned overlapping 

of Absorb BVS was disallowed. Any bailout must be done with overlapping a XIENCE V stent 

of appropriate length, and if not available, a CYPHER

®

 sirolimus-eluting stent; bailout with 

Absorb BVS was not permitted. Postdilatation was performed at operator discretion, but only 

using balloons sized to fit within the boundaries of the scaffold.

Antiplatelet Regimen:

 Subjects not on chronic antiplatelet medications had to receive a 

loading dose of clopidogrel bisulfate ≥ 300 mg and aspirin ≥ 300 mg 6 to 72 hours prior to 

the index procedure if possible, but no later than 1 hour after the procedure. All patients were 

required to receive anticoagulation and other therapy during scaffold implantation according 

to the standard of care at the clinical site. All patients were to be maintained on 75 mg 

clopidogrel bisulfate daily for a minimum of 6 months and ≥ 75 mg of aspirin daily for the 

length of the clinical investigation (5 years). Patients who developed sensitivity to clopidogrel 

bisulfate were to be switched to ticlopidine hydrochloride at a dose in accordance with 

standard hospital practice.

8.2 

ABSORB Cohort A

8.2.1   Methodology and Current Status

A total of 30 patients in Cohort A were enrolled between March 7, 2006 and July 18, 2006 at 

four clinical sites in Europe and New Zealand.

The ABSORB Cohort A Trial implanted the Absorb Cohort A BVS in patients with a single 

de novo

 native coronary artery lesion. Enrollment started with the 3.0 x 12 mm size. The  

3.0 x 18 mm size became available later during enrollment and was used in only two 

patients.

Clinical follow-up through 30 days, 180 days, 270 days, 1 year, 18 months, 2 years, 3 years, 

4 years, and 5 years, and angiographic, IVUS, IVUS-VH, palpography, OCT data at 180 days 

and 2 years are available. MSCT data at 18 months and coronary vasomotor test data at 

2 years are also available. No further clinical observations will be performed for ABSORB 

Cohort A since 5-year follow-up was the last visit time point.

8.2.2   Clinical Outcome at 5 Years

At 5 years, the ischemia-driven MACE (defined as the composite endpoint of cardiac death, 

MI or ID-TLR) rate was 3.4% (

Table 4

). There was only one non-Q-wave MI (peak troponin 

2.21 μg/L) related to the treatment of a non-flow-limiting stenosis (QCA diameter stenosis 

42%) of an Absorb BVS implanted 46 days earlier, in a patient who had one episode of 

angina at rest without electrographic evidence of ischemia. For a perceived safety reason, 

the polymeric scaffold was covered by a drug-eluting metallic stent. No new MACE was 

recorded between 6 months and 5 years. No instances of scaffold thrombosis arose 

according to the protocol or the Academic Research Consortium (ARC) definitions.

Table 4: Clinical Outcome at 5 years

Hierarchical 

Rates

6 Months 

(N = 30)

12 Months 

(N = 29)

2 years 

(N = 29)

3 years 

(N = 29)

4 years 

(N = 29)

5 years 

(N = 29)

Cardiac 

Death, %

0

0

0

0

0

0

MI, % (n)

3.3 (1)*

3.4 (1)*

3.4 (1)*

3.4 (1)*

3.4 (1)*

3.4 (1)*

Q-Wave MI

0

0

0

0

0

0

EL2103340 (4/24/15) 

Page 5 of 137

RELEASED

RELEASED

Printed on : 04/29/2015

Содержание Absorb GT1 Bioresorbable Vascular Scaffold...

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Страница 4: ...adequate lesion preparation or a lesion with greater than 40 residual stenosis after predilatation by visual estimation 6 0 PRECAUTIONS 6 1 Scaffold Handling Precautions For single use single insertio...

Страница 5: ...stem All other adverse events are included in section 7 2 Potential Adverse Events 7 2 Potential Adverse Events Adverse events that may be associated with PCI treatment procedures and the use of a cor...

Страница 6: ...e been reported through 4 years The overall MACE rate at 4 years was 10 1 and there have been no cases of cardiac death or scaffold thrombosis per protocol or per ARC definitions The 4 year full Cohor...

Страница 7: ...ifference in outcomes between the Absorb BVS System and the XIENCE V EECSS p 0 68 Similarly differences in the in device diameter stenosis in segment late loss and in segment diameter stenosis were no...

Страница 8: ...are lifted Do not use if any defects are noted 10 4 3 Guide Wire Lumen Flush Flush the guide wire lumen with HepNS until fluid exits the guide wire exit notch Note Avoid manipulation of the scaffold w...

Страница 9: ...nisse nach 1 Jahr anhand der IPSW adjustierten Kohorten 8 5 3 2 j hrige Propensity Analyse Tabelle 11 Klinische Ergebnisse nach 2 Jahren anhand der IPSW adjustierten Kohorten 8 6 ABSORB II RCT 8 6 1 S...

Страница 10: ...Wirksamkeit des Absorb GT1 BVS bei Patienten mit fr herer Brachytherapie der Ziell sion bzw Brachytherapie zur Behandlung einer Restenose in einem Absorb GT1 BVS wurden nicht untersucht Sowohl vaskul...

Страница 11: ...Kohorte A wurden zwischen dem 7 M rz 2006 und dem 18 Juli 2006 an vier klinischen Pr fzentren in Europa und Neuseeland aufgenommen Das f r Kohorte A vorgesehene Absorb BVS wurde im Rahmen der ABSORB...

Страница 12: ...ber 0 28 0 41 mm2 nach 3 Jahren p 0 0001 erhalten blieb Die OCT Ergebnisse nach 3 Jahren N 18 spiegeln ebenfalls die Ger stvergr erung zwischen 1 Jahr und 3 Jahren wider mittlere Ger stfl che 7 51 0 9...

Страница 13: ...orb BVS und XIENCE V die anhand des Ger st Stent internen Lumenverlusts nach 6 Monaten nur Kohorte B sowie den klinischen Ergebnissen nach 6 Monaten und 1 Jahr deutlich wurde bestand bis 2 Jahre nach...

Страница 14: ...beachten 2 Vor der Entfaltung erneut mithilfe der r ntgendichten Ballonmarkierungen die korrekte Ger stposition in Relation zur Ziell sion best tigen 3 Das Ger st langsam entfalten indem in Schritten...

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Страница 16: ...nonc IRM Une comparaison r alis e par rapport aux endoproth ses m talliques XIENCE PRIME r v le que le support vasculaire bior sorbable BVS Absorb GT1 est compatible avec l IRM sous conditions et qu...

Страница 17: ...vation principale fournie par l chographie intravasculaire en chelle de gris tait l augmentation de la surface minimale de la lumi re et de la surface ou du volume moyen de la lumi re ainsi qu une dim...

Страница 18: ...bior sorbable BVS Absorb pourront participer l tude ABSORB EXTEND Le support vasculaire bior sorbable BVS Absorb de 3 0 x 18 mm est disponible depuis le d but des inscriptions dans l essai Les mod les...

Страница 19: ...bles celles du syst me XIENCE Les taux d ELC et d EICM 1 an taient comparables entre les deux bras utilisant le dispositif 4 8 contre 3 0 pour l ELC p 0 3473 et 5 2 contre 3 0 pour les EICM p 0 2832 A...

Страница 20: ...ndes D ployer compl tement le support en faisant passer la pression nominale au minimum Selon la pratique accept e on vise g n ralement une pression de d ploiement initiale permettant d atteindre un r...

Страница 21: ...RESENTACI N Est ril este dispositivo ha sido esterilizado con haz de electrones Apir geno No utilizar el producto si el envase est abierto o da ado Este dispositivo de un solo uso no se puede reutiliz...

Страница 22: ...imus como medicaci n oral puede interaccionar con algunos f rmacos o alimentos1 2 3 4 5 lo que incluye sin limitarse a los mismos los siguientes Inhibidores de la CYP3A4 y la PgP que pueden aumentar l...

Страница 23: ...ada tasa de xito inmediato y seguridad en los 30 d as siguientes a la implantaci n 100 de xito de la intervenci n 94 de xito del dispositivo y una revascularizaci n satisfactoria de la lesi n a tratar...

Страница 24: ...rigen card aco 15 IM y 2 RVT II LNT jer rquicamente La muerte de un paciente a los 108 d as se consider de origen card aco seg n la definici n del ARC de muerte de origen card aco 0 2 a los 194 d as 1...

Страница 25: ...rici n gradual del armaz n existe la posibilidad de que el vaso se cure y se restablezca la funci n vascular como se explica en el ep grafe Resultados de la funci n vasomotora a los 2 a os apartados 8...

Страница 26: ...e sea adecuada para garantizar que el armaz n no se dilate en exceso El l mite de dilataci n del armaz n es de 0 5 mm por encima del di metro nominal en todos los tama os de armaz n PRECAUCI N No sobr...

Страница 27: ...d L impianto dello scaffold va effettuato solo da medici che abbiano ricevuto un training appropriato Il posizionamento dello scaffold va eseguito soltanto nei centri ospedalieri dove sia possibile ef...

Страница 28: ...to dello scaffold densit del farmaco marker permanenti dello scaffold e struttura dello scaffold L Absorb GT1 BVS differisce dall Absorb BVS solo nel sistema di rilascio dello scaffold Il sistema di r...

Страница 29: ...perplasia neointimale nello scaffold la percentuale dell ostruzione dell area nello scaffold e l iperplasia neointimale erano minime rispettivamente 1 43 e 0 09 mm2 Nel corso del tempo si verificato u...

Страница 30: ...ggruppati dalla Coorte B e un set di dati provvisori di ABSORB EXTEND e 905 pazienti XIENCE V raggruppati da SPIRIT FIRST SPIRIT II e SPIRIT III con un follow up di 1 anno a prescindere dalle dimensio...

Страница 31: ...o 10 4 4 Preparazione del sistema di rilascio 1 Preparare un dispositivo di gonfiaggio siringa con mezzo di contrasto diluito 2 Collegare un dispositivo di gonfiaggio siringa al rubinetto quindi colle...

Страница 32: ...implantada do sistema de entrega da plataforma O sistema BVS Absorb GT1 possui um sistema de entrega da plataforma de troca r pida RX Dois marcadores proximais do eixo do sistema de entrega 95 cm e 10...

Страница 33: ...n o expandida s pode ser retra da para o cateter guia uma nica vez Uma plataforma n o expandida n o deve ser reintroduzida na art ria depois de ter sido retra da para o cateter guia N o se deve execut...

Страница 34: ...e na Nova Zel ndia No estudo de Coorte A ABSORB o BVS de Coorte A Absorb foi implantado em doentes com uma nica les o de novo da art ria coron ria nativa A inscri o come ou com o tamanho 3 0 x 12 mm...

Страница 35: ...p s 3 anos p 0 0001 Os resultados de OCT a 3 anos N 18 revelaram tamb m um aumento da plataforma entre 1 e 3 anos rea m dia da plataforma de 7 51 0 95 mm2 ap s 1 ano vs 8 64 2 15 mm2 ap s 3 anos p 0 0...

Страница 36: ...e 95 0 6 0 01 3 09 1 4 0 37 3 46 0 65 Nota Os componentes morte card aca EM e ID TLR s o apresentados de uma forma n o hier rquica Discuss o A comparabilidade entre o BVS Absorb e o XIENCE V demonstra...

Страница 37: ...ntes da implanta o reconfirmar a posi o correcta da plataforma em rela o les o alvo com os marcadores de bal o radiopacos 3 Implantar a plataforma pressurizando lentamente o sistema de entrega em incr...

Страница 38: ...och risk f r patient och eller anv ndarskada Inneh ll Ett 1 Absorb GT1 system med bioresorberbar vaskul r scaffold en 1 TagAlert temperaturmonitor F rvaring F rvaras vid eller under 25 C 77 F avvikel...

Страница 39: ...onar scaffold i nativa kransart rer inkluderar men r ej begr nsade till f ljande pl tslig k rlavst ngning komplikationer vid punktionsst llet allergisk reaktion eller verk nslighet mot kontrastmedel p...

Страница 40: ...n kohort B1 begr nsad neointimal hyperplasi i scaffolden volymobstruktionen VO var 1 2 N 40 och arean f r den neointimala hyperplasin var 0 08 mm2 N 40 Dessa resultat kan m ta sig med resultaten f r X...

Страница 41: ...64 0 77 4 51 2 52 1 25 3 80 0 92 ID TLR 95 KI 1 95 0 33 3 56 3 10 1 70 4 51 0 33 TLF 95 KI 4 15 1 82 6 47 5 09 3 30 6 87 0 54 Definitiv sannolik scaffold stenttrombos 95 KI 0 40 0 0 1 14 0 52 0 0 1 11...

Страница 42: ...strumentet ppna den roterande hemostasventilen s mycket som m jligt 5 Ladda b rarsystemet bakifr n p ledarens proximala del samtidigt som ledarens position bibeh lls ver m llesionen 6 F r in b rarsyst...

Страница 43: ...ioneren zoals bedoeld Veranderingen in mechanische fysische en of chemische eigenschappen door herhaald gebruik reiniging en of hersterilisatie kunnen de integriteit van het ontwerp en of de materiale...

Страница 44: ...vaatwand wanneer wordt besloten om de Absorb GT1 BVS bij een pati nt te implanteren die een geneesmiddel gebruikt waarvan bekend is dat het met everolimus interageert Everolimus voorgeschreven in oral...

Страница 45: ...ngiografisch vastgesteld verlies van 0 43 mm op de lange termijn gezien dit was meer dan eerder werd waargenomen bij de XIENCE V stent na 6 maanden SPIRIT FIRST en werd mogelijk veroorzaakt door bioac...

Страница 46: ...8 1 Daarnaast bedroeg het percentage zekere waarschijnlijke trombose in de steun tot aan 758 dagen voor deze populatie volgens de ARC definitie 0 8 Tabel 7 Aantallen pati nten met door ischemie veroo...

Страница 47: ...ische onderzoeken in combinatie met de actuele literatuur over geneesmiddel eluerende stents steunen en de specifieke behoeften van de individuele pati nt om aan de hand hiervan in hun algemene prakti...

Страница 48: ...1 mm en maximaal 4 mm overlappen om het risico van restenose in de ruimte tussen de steunen te voorkomen Om ervoor te zorgen dat er geen leemte tussen steunen ontstaat moeten de ballonmarkeringen van...

Страница 49: ...dotelialiserede stilladser kendes ikke p nuv rende tidspunkt 6 2 Anl ggelse af stilladset Forsigtighedsregler Fremf ringssystemet m ikke klarg res eller pr dilateres f r anl ggelse af stilladset udove...

Страница 50: ...af ca 101 patienter kohorte B p 12 kliniske centre i Europa og Asien Stillehavsomr det Egnethedskriterier Patienter p mindst 18 r med tegn p angina myokardieisk mi eller en positiv funktionstest kvin...

Страница 51: ...95 mm2 efter 1 r vs 8 64 2 15 mm2 efter 3 r p 0 0008 Lumenarealet forblev relativt konstant 6 01 1 29 mm2 efter 1 r vs 6 09 1 67 mm2 efter 3 r p 0 679 Kararealet blev ikke m lt da OCT ikke kan afgr ns...

Страница 52: ...en morfologiske samt funktionelle respons vil blive vurderet efter 3 r baseret p billeddiagnostik som vil omfatte angiografi IVUS IVUS virtuel histologi og LipiScan med MSCT vurderet efter 3 r 8 6 2 O...

Страница 53: ...vis det er n dvendigt kan fremf ringssystemet s ttes under tryk igen eller under yderligere tryk for at sikre fuldst ndig apposition af stilladset til arteriev ggen D k hele l sionen og det omr de der...

Страница 54: ...3 3 0 28 6F 0 070 1 8 mm 7 709 16 1621 73 3 5 12 6F 0 070 1 8 mm 6 608 16 1621 73 3 5 18 6F 0 070 1 8 mm 6 608 16 1621 73 3 5 23 6F 0 070 1 8 mm 6 608 16 1621 73 3 5 28 6F 0 070 1 8 mm 6 608 16 1621 7...

Страница 55: ...europa eu www fda gov 8 0 ABSORB BVS Absorb GT1 BVS Absorb BVS 8 0 Absorb BVS Absorb GT1 BVS Absorb BVS Absorb GT1 BVS Absorb BVS Absorb GT1 RX Abbott Vascular Absorb GT1 Absorb Absorb GT1 BVS Absorb...

Страница 56: ...ECSS SPIRIT FIRST First In Man 0 43 mm N 26 A 180 IVUS B1 VO 1 2 N 40 0 08 mm2 N 40 XIENCE V EECSS SPIRIT FIRST VO 8 0 N 21 NIH 0 56 mm2 N 21 VO 5 3 N 25 NIH 0 29 mm2 N 25 IVUS 6 6 60 1 22 mm2 N 37 6...

Страница 57: ...E V Absorb BVS 6 1 Absorb BVS XIENCE V inverse propensity score weighted IPSW 1 8 5 1 6 B 1 ABSORB 73 XIENCE V 3 0 x 18 mm SPIRIT FIRST SPIRIT II QCA 6 6 MACE 6 2 63 1 38 4 11 3 73 34 Absorb BVS 66 XI...

Страница 58: ...5 5 2 73 7 49 0 76 0 13 TLR 1 2 1 8 0 61 4 08 1 61 0 69 TVR nonTLR 1 8 3 6 1 82 6 28 0 67 0 23 NTVR 1 8 3 6 1 82 6 00 1 05 0 23 3 6 7 3 3 64 8 88 0 39 0 076 TLF TVMI ID TLR 4 8 3 0 1 82 2 46 5 18 0 3...

Страница 59: ...trznaczyniowej IVUS i OCT po 180 dniach 1 roku 2 oraz 3 latach 8 3 4 Om wienie 8 4 ABSORB EXTEND 8 4 1 Metodologia i stan obecny 8 4 2 Zestawienie wynik w klinicznych z okresu 1 roku z odci ciem danyc...

Страница 60: ...zenie pow oki kontaminacj lub od czenie rusztowania od balonika systemu zak adania Nale y u ywa wy cznie odpowiedniego rodka do nape niania balonika Nie nale y u ywa do tego celu powietrza ani innych...

Страница 61: ...rdziowy Obrz k obwodowy Wysi k op ucnowy Zapalenie p uc Gor czka Wysypka Niewydolno nerek Zaka enia g rnych dr g oddechowych Zaka enie dr g moczowych ylna choroba zakrzepowo zatorowa Wymioty Powik ani...

Страница 62: ...w grupie A N 26 Po 180 dniach wyniki badania IVUS w grupie B1 pokaza y ograniczony przerost neointimy w rusztowaniu zmniejszenie obj to ci VO wynios o 1 2 N 40 a powierzchnia przerostu neointimy wynos...

Страница 63: ...wia o nieznamienn statystycznie r nic w wynikach pomi dzy systemem Absorb BVS i XIENCE V EECSS p 0 68 Podobnie wyniki w zakresie rednicy stenozy w urz dzeniu p nej utraty wiat a w segmencie i rednicy...

Страница 64: ...dokonywany jest na podstawie decyzji lekarza 10 4 Przygotowanie urz dzenia 10 4 1 Zdejmowanie opakowania Uwaga Torebka foliowa stanowi steryln barier Produkt sterylny jest zawarty w tej jednej torebce...

Страница 65: ...haemia okozta mell khat sok jelentkeztek 393 napos id szak alatt az sszes regisztr lt alany 8 4 3 A klinikai eredm nyek sszefoglal sa a 2 vig el zetes adatok 7 t bl zat ABSORB EXTEND alanyok akikn l i...

Страница 66: ...teljesen elfedje az Absorb GT1 BVS rendszert Minden hirtelen elz r d st a k rh z s rg ss gi ell t si protokolljai szerint kell kezelni Megjegyz s A s rg ss gi behelyez seket megfelel m ret f mes ever...

Страница 67: ...l MI vagy ischaemia miatti TLR n 3 3 1 3 4 1 3 4 1 3 4 1 3 4 1 3 4 1 rt masztromb zis 0 0 0 0 0 0 Megjegyz sek A nevez kiz rja azokat az alanyokat akiknek nincsenek ut nk vet si adataik s akikn l a k...

Страница 68: ...i vizsg l helyr l Minden beteg eset ben maximum k t k l nb z epicardialis v red nyben lev de novo nat v koszor r l zi t kezelnek Azok a betegek ker lhetnek be a ABSORB EXTEND vizsg latba akikn l a c l...

Страница 69: ...kus sz m t sok Hal l 0 0 0 6 0 61 3 35 0 65 0 33 Sz vhal l 0 0 0 0 0 00 NA 1 00 MI sszesen 4 5 1 2 3 33 0 24 6 29 0 055 QMI 0 6 0 0 0 61 1 71 2 18 0 55 NQMI 3 9 1 2 2 73 0 77 5 55 0 095 Sztent rt masz...

Страница 70: ...s a vezet kat tert egy egys gk nt kell elt vol tani Ezt k zvetlen fluoroszk pi s ellen rz s mellett kell v gezni 7 Szor tsa meg a forg v rz sg tl szelepet Ezzel az rt masz k szen ll a kinyit sra 10 6...

Страница 71: ...tila jej adekv tn apozice Sn te t m riziko po kozen opory P i zav d n zav d c ho syst mu do c vy na n j neaplikujte podtlak M e to zp sobit uvoln n opory z balonku Neot ejte katetrem o v ce ne jednu 1...

Страница 72: ...edeno p ekryt m pomoc stentu XIENCE V vhodn d lky a pokud nen tento stent k dispozici mus se pou t stent CYPHER vylu uj c sirolimus bailout se syst mem Absorb BVS nebylo p pustn Postdilatace byla prov...

Страница 73: ...po 3 letech N 18 rovn odhalily zv t en opory mezi 1 a 3 lety st edn plocha opory 7 51 0 95 mm2 po 1 roce vs 8 64 2 15 mm2 po 3 letech p 0 0008 Plocha lumen z stala relativn konstantn 6 01 1 29 mm2 v 1...

Страница 74: ...18 mm a 3 5 x 28 mm Koprim rn endpointy byly 1 vazomotorika vyhodnocen podle zm ny st edn ho pr m ru lumen pre a postnitr t po 3 letech nad azen a 2 minim ln pr m r lumen po 3 letech post nitr t m nus...

Страница 75: ...mu lze napomoci pou it m rutinn angiografie intravaskul rn ho ultrazvuku IVUS nebo optick koherentn tomografie OCT 8 Postdilataci pomoc nonkompliantn ho balonku se doporu uje prov st podle pokyn uvede...

Страница 76: ...rme sistemi damar i ine girerken yerle tirme sistemi zerinde negatif bas nca neden olmay n Bu iskelenin balondan kmas na neden olabilir Katetere bir 1 tam d n ten fazla tork uygulamay n Absorb GT1 BVS...

Страница 77: ...trombus i eren hedef damar hedef damar veya yan dalda klinik olarak nemli ba ka lezyonlar Tedavi Stratejisi Hedef lezyonun n dilatasyonu zorunluydu Absorb BVS nin planlanan st ste binmesine izin veri...

Страница 78: ...k Klinik Sonu lar n zeti Ge ici Veri Kesme 2 y ll k 758 g n 19 Temmuz 2013 veri kesintisi takibe ula an ilk 250 hastan n alt grubunda bir kardiyak l m vakas vard ve 758 g nl k MACE ile oran d kt 7 3 T...

Страница 79: ...performans XIENCE ile benzerdir Bir y ll k TLF ve MACE oranlar iki cihaz kolu aras nda kar la t r labilirdir TLF i in 4 8 e kar 3 0 p 0 3473 ve 5 2 ye kar MACE i in 3 0 p 0 2832 Ne Absorb BVS ne de X...

Страница 80: ...n yap lan segment iskelenin izin verilebilir geni leme s n rlar dahilinde oldu u s rece esnek olmayan nominal iskele ap ndan 0 5 mm ye kadar geni bir balonla postdilatasyon yap lmas nerilir skele geom...

Страница 81: ...tiu cievnej v stu e na zaistenie primeranej apoz cie v stu e Zn i to riziko po kodenia v stu e Pri zav dzan zav dzacieho syst mu do cievy nevystavujte zav dzac syst m podtlaku To m e sp sobi posunutie...

Страница 82: ...krit ri vyl enia aorto osti lne umiestnenie av hlavn umiestnenie do 2 mm od za iatku avej prednej zostupnej vetvy LAD alebo avej cirkumflexnej vetvy LCX nadmern skr tenie proxim lne k l zii alebo v r...

Страница 83: ...sa zv il av ak zostal minim lny po 2 rokoch 1 43 oproti 2 11mm2 p 0 0001 a stredn prierez l menu zostal nezmenen Okrem toho sa stredn v stu ov plocha zv ila zo 7 47 na 8 24 mm2 p 0 0155 od z kroku do...

Страница 84: ...ke 11 Tabu ka 11 Klinick v sledky po 2 rokoch z kohort s pravou IPSW Klinick v sledky po 2 rokoch Absorb BVS N 178 XIENCE V N 293 Hodnota p Srdcov smr 95 CI 0 0 0 00 2 05 1 4 0 37 3 46 0 30 IM 95 CI 4...

Страница 85: ...Tento postup vykon vajte pomocou priamej fluoroskopickej vizualiz cie 7 Utiahnite oto n hemostatick ventil V stu je teraz pripraven na rozvinutie 10 6 Postup rozvinutia 1 UPOZORNENIE Vn torn priemer...

Страница 86: ...ro mm mm in vitro RBP atm kPa atm kPa 2 5 8 6F 0 070 1 8 mm 6 608 16 1621 68 2 5 12 6F 0 070 1 8 mm 6 608 16 1621 68 2 5 18 6F 0 070 1 8 mm 6 608 16 1621 68 2 5 23 6F 0 070 1 8 mm 6 608 16 1621 68 2 5...

Страница 87: ...sorb GT1 BVS everolimus 7 0 7 1 ABSORB MI Q Q TLR PCI MACE MI TLR ID TLR 8 0 Absorb BVS 7 2 7 2 PCI L PLLA D L PDLLA TIA everolimus 1 5 mg 10 mg SPC 1 2 3 4 5 everolimus 10 everolimus 1 2 3 4 5 everol...

Страница 88: ...56 2 1 3 B 6 2009 6 9 1 2 3 IVUS 2 1 1 3 2 5 8 3 2 B 5 4 ABSORB 101 5 B ITT 30 6 9 1 2 3 4 N 101 N 101 N 101 N 101 N 100 N 100 N 99 0 0 0 0 0 0 0 MI n 2 0 2 3 0 3 3 0 3 3 0 3 3 0 3 3 0 3 3 0 3 MI Q 0...

Страница 89: ...XTEND 30 N 250 30 7 6 N 250 180 14 1 N 250 365 28 2 N 250 730 28 MACE 2 0 5 250 2 8 7 250 4 4 11 250 7 3 18 248 TVF 2 0 5 250 3 2 8 250 4 8 12 250 8 1 20 248 TLF 2 0 5 250 2 8 7 250 4 4 11 250 6 9 17...

Страница 90: ...55 MI Q 0 6 0 0 0 61 1 71 2 18 0 55 MI Q 3 9 1 2 2 73 0 77 5 55 0 095 ARC 0 6 0 0 0 6 11 7 2 16 1 00 TLR 1 2 1 8 0 61 4 08 1 61 0 69 TVR 0 9 1 8 0 91 4 35 1 19 0 41 NTVR 1 5 2 4 0 91 4 65 1 56 0 49 2...

Страница 91: ...iei ale ecografiei intravasculare IVUS i ale tomografiei n coeren optic OCT la 180 de zile 1 2 i 3 ani 8 3 4 Discu ii 8 4 ABSORB EXTEND 8 4 1 Metodologie i situa ia actual 8 4 2 Rezumatul rezultatelor...

Страница 92: ...a efectuat anterior brahiterapie a leziunii int sau a utiliz rii brahiterapiei pentru restenozarea zonei tratate din interiorul unui EVS Absorb GT1 At t brahiterapia vascular c t i EVS Absorb GT1 modi...

Страница 93: ...orb se poate estima c performan a EVS Absorb GT1 va fi similar cu cea a EVS Absorb Prin urmare datele provenite din studiile clinice pentru EVS Absorb sunt prezentate pe scurt n aceast sec iune 8 1 St...

Страница 94: ...m2 p n la 1 an 6 33 1 17 mm2 n urma OCT nu a existat nicio modificare semnificativ a suprafe ei medii i minime a e afodajului dup procedur i p n la 1 an N 21 S a nregistrat o reducere a suprafe ei lum...

Страница 95: ...a i din Cohorta B i un set de date interimare din cadrul ABSORB EXTEND i 905 pacien i XIENCE V extra i din cadrul SPIRIT FIRST SPIRIT II i SPIRIT III cu monitorizare de 1 an indiferent de dimensiunile...

Страница 96: ...lui de ghidare Not Evita i manevrarea e afodajului c nd sp la i lumenul firului de ghidare deoarece acest lucru poate afecta amplasarea e afodajului pe balona 10 4 4 Preg tirea sistemului de amplasare...

Страница 97: ...e n cateterul de ghidare ntregul sistem trebuie retras n bloc Consulta i sec iunea 6 4 Retragerea e afodajului sistemului M suri de precau ie pentru instruc iuni specifice de retragere a sistemului de...

Страница 98: ...GT1 Absorb GT1 Absorb 94 Absorb GT1 Absorb GT1 Absorb GT1 10 7 Absorb GT1 6 4 Absorb GT1 6 3 Absorb GT1 6 4 1 30 2 3 4 5 1 1 5 2 6 5 9 1 6 6 XIENCE PRIME Absorb GT1 3 2500 SAR 2 0 15 Absorb GT1 Absorb...

Страница 99: ...72 1 75 6 75 5 8 2 ABSORB A 8 2 1 A 30 7 2006 18 2006 Absorb de novo 3 0 x 12 3 0 x 18 2 30 180 270 1 18 2 3 4 5 VH 180 2 18 2 ABSORB 5 8 2 2 5 5 ID TLR 3 4 4 Q 2 21 QCA 42 46 Absorb 6 5 Academic Res...

Страница 100: ...18 SPIRIT FIRST 1 2 N 54 1 43 0 09 2 6 31 0 95 2 1 6 33 1 17 2 1 n 21 1 34 0 67 2 20 2 26 9 1 2 1 B B1 0 27 n 38 1 B2 B SPIRIT II 0 33 n 83 XIENCE V 2 n 33 Absorb 6 2 6 42 7 08 2 p 0 0001 6 36 6 85 2...

Страница 101: ...scular XIENCE V Absorb 6 1 Absorb XIENCE V IPSW 1 2 8 5 1 6 6 38 1 ABSORB 73 XIENCE V 3 0x18 SPIRIT FIRST SPIRIT II QCA 6 MACE 6 2 63 1 38 4 11 3 73 34 Absorb 66 XIENCE V 38 73 6 6 2 01 0 7 34 5 27 3...

Страница 102: ...29 0 055 Q 0 6 0 0 0 61 1 71 2 18 0 55 Q 3 9 1 2 2 73 0 77 5 55 0 095 ARC 0 6 0 0 0 6 11 7 2 16 1 00 1 2 1 8 0 61 4 08 1 61 0 69 Absorb N 335 XIENCE N 166 95 P 0 9 1 8 0 91 4 35 1 19 0 41 1 5 2 4 0 91...

Страница 103: ...3 4 5 6 7 10 6 1 in vitro 2 3 2 5 30 1 1 16 1621 4 5 Absorb GT1 6 30 10 8 7 O T 8 10 7 10 7 1 0 5 0 5 0 5 2 5 3 00 3 00 3 50 3 5 4 00 2 Absorb GT1 1 4 Absorb GT1 Absorb GT1 3 10 8 1 30 2 3 4 5 6 1 5...

Страница 104: ...ytt inen Ota TagAlert monitori laatikosta ja h vit paikallisten s nn sten mukaan B Ei saa k ytt 2 0 TOIMITUSTAPA Steriili T m laite on steriloitu elektronisuihkus detysmenetelm ll Pyrogeenit n Ei saa...

Страница 105: ...ptiini simetidiini danatsoli CYP3A4 n induktorit jotka saattavat v hent everolimuusil kkeen m r antibiootit esim rifampisiini rifabutiini epilepsial kkeet esim karbamatsepiini fenobarbitaali fenytoiin...

Страница 106: ...t l keaineella oli positiivinen vaikutus uudelleenahtautumisen est misess 2 vuoden seurannassa angiografiatulokset osoittivat hyv ksytt v tukirakenteen menetyst 0 48 mm 2 vuoden j lkeen ja v h ist muu...

Страница 107: ...mukainen ei hierarkkinen kokonais MI m r oli 2 9 13 450 9 NQMI ja 4 QMI tapahtumaa 8 4 3 2 vuoden ajalta saatujen kliinisten tulosten yhteenveto tietojen v lianalyysi Ensimm isten 250 potilaan alaryhm...

Страница 108: ...2 vuoden seurannassa 8 2 5 Tutkimusl yd sten tarkastelu Pysyv n metalli implantin puuttuminen verisuonikudoksesta voi helpottaa kohdesuonen ahtauman tai sivuhaarojen my hemmin joko perkutaanisin tai k...

Страница 109: ...laajennetaan liikaa Tukirakenteen nimellisl pimitta Laajentamisraja 2 5 mm 3 00 mm Laajennuksen j lkeinen enimm isl pimitta 3 00 mm 3 50 mm Laajennuksen j lkeinen enimm isl pimitta 3 5 mm 4 00 mm Laa...

Страница 110: ...krives i avsnitt 10 4 4 Klargj ring av utleggingssystemet Utf r en omhyggelig m ling av diameteren p referansem llesjonen for unng overekspansjon av stillaset og dermed sikre god stillasplassering Det...

Страница 111: ...aorto ostial plassering venstre hovedplassering innenfor 2 mm fra utgangspunktet for LAD eller LCX sterk vridning proksimalt for eller i lesjonen ekstrem vinkling 90 sterk forkalkning restenose fra t...

Страница 112: ...for de 45 pasientene i kohort B1 og etter 1 r og 3 r for de 56 pasientene i kohort B2 Totalt har Absorb BVS systemet vist akutt suksess 98 prosedyresuksess og 100 enhetssuksess og sikkerhet opptil 3...

Страница 113: ...sienter Absorb BVS N 335 XIENCE N 166 Data fra ett rig oppf lging er oppsummert i dette avsnittet Som vist i Tabell 12 var den totale sikkerheten og ytelsen til Absorb BVS tilsvarende XIENCE De 1 rige...

Страница 114: ...kontakt med arterieveggen 5 Ved behov kan utleggingssystemet trykksettes p nytt eller trykksettes mer for sikre fullstendig anleggelse av stillaset mot arterieveggen Dekk hele lesjonen og det ballongb...

Страница 115: ...ino enot Rapid Exchange Kiirvahetus tr apmai a Greitasis keitimas Hitra izmenjava Non pyrogenic Mittep rogeenne Nepirog ns Nepirogeninis Apirogeno Separate collection for waste electrical electronic...

Страница 116: ...d pol meer pol L laktiidist PLLA toes mis on kaetud antiproliferatiivse ravimi everoliimuse ja pol meer pol D L laktiidi PDLLA seguga suhtes 1 1 Everoliimuse kogus toesel on esitatud tabelis 1 Tabel 1...

Страница 117: ...ainet sest see v ib p hjustada eba htlast laienemist ja takistada toese paigaldamist Toese implantatsiooni tohivad teha ainult vastava v lja ppega arstid Toese implantatsiooni tohib teha vaid haiglate...

Страница 118: ...rselt protseduurij rgse ja 180 p eva vahelisel ajal aga suurenesid arvuliselt 180 p eva ja 2 aasta vahelisel ajal 8 2 4 Vasomotoorse talitluse tulemused 2 aastasel j lgimisel Ravitud toestatud segmen...

Страница 119: ...onile koos struktuurse tervikluse v henemisega See n htus on bioresorbeeruvate vaskulaarsete toeste ainulaadne omadus v rreldes IVUS i metalliliste DES ide sari piltdiagnostikaga kus valendiku hilisem...

Страница 120: ...eduuri ohte ja eeliseid ning antiagregatiivse ravi enneaegse v i ajutise l petamisega kaasnevat v imalikku ohtu Patsiente kellel antiagregatiivne ravi tuleb enneaegselt l petada t sise aktiivse verejo...

Страница 121: ...UST rge laiendage toest le dilatatsiooni piiri mis on 0 5 mm le nimidiameetri lelaiendamine v ib toest kahjustada Toese nimidiameeter Dilatatsiooni piir 2 5 mm 3 00 mm Maksimaalne j reldilatatsiooni d...

Страница 122: ...t mu uzman gi ievelciet vad t jkatetr Ja ievelkot korpusu vad t jkatetr k d br d j tama neierasta pretest ba karkasa pieg des sist ma un vad t jkatetrs j iz em k vienota ier ce Tas j veic ar tie as vi...

Страница 123: ...mm boj juma garums 8 mm p c vizu l v rt juma papla in ts l dz 14 mm 3 0 x 18 mm karkasam stenozes diametrs DS 50 un 100 trombol zes miokarda infarkt Thrombolysis in Myocardial Infarction TIMI pl sma...

Страница 124: ...ve 15 MI un 2 ID Non TL TVR hierarhiski Viens pacients kur nomira 108 dien tika iek auts kardi l s n ves sarakst atbilst gi kardi l s n ves ARC defin cijai 0 2 194 dien s 1 537 pacienta m r a boj jum...

Страница 125: ...mos kas ietvers angiogr fiju IVUS IVUS virtu lo histolo iju un Lipiscan k ar MSCT izv rt anu p c 3 gadiem 8 6 2 Kl nisko rezult tu datu kopsavilkums P t jum ABSORB II RCT re istr cija tika pabeigta 20...

Страница 126: ...6 2 Karkaso d jimas Atsargumo priemon s 6 3 Naudojimas kartu atliekant kitas proced ras 6 4 Karkaso sistemos i mimas Atsargumo priemon s 6 5 Po implantacijos Atsargumo priemon s 6 6 MRT galimyb 6 7 V...

Страница 127: ...m ir kreipiam j kateter kaip vien prietais Tai darykite tiesiogiai steb dami fluoroskopu Karkaso vedimo sistemos perpl timo balion lio i traukimas i i pl sto karkaso 1 Prip timo prietaisu sudar neigia...

Страница 128: ...mo kraujagysl je Tod l vizualin s OKT savyb s matomos atramos ne visuomet rodo rezorbcijos nebuvim ta iau OKT matomos atramos nebuvimas patvirtina rezorbcij Spind io forma buvo tolygi su lygiais ai ki...

Страница 129: ...emin s ne TL TVR da nis buvo 0 6 3 537 d l 2 i emini ne TL TVR vyki atlikus AKJO ir 1 i emin s ne TL TVR vykio atlikus PCI pasirei kimo 1 ais metais MACE da nis buvo 4 2 19 450 1 kardialin mirtis 13...

Страница 130: ...enduojamas gydymas antiagregantais yra tinkamas PCI pasirinkimas Po PCI jeigu rekomenduojama chirurgin ar dant proced ra reikia pasverti rizik ir naud d l galim pavoj susijusi su gydymo antiagregantai...

Страница 131: ...orta B pri klini nem presku anju ABSORB 8 3 1 Metodologija in trenutno stanje 8 3 2 Klini ni izidi za celotno kohorto B Tabela 5 Hierarhi ni klini ni izidi za kohorto B populacija predvidena za zdravl...

Страница 132: ...ije sestavljeni iz sr ne smrti miokardnega infarkta revaskularizacije ciljne lezije zaradi ishemije so navedeni v poglavju 8 0 Klini ne preiskave sistema biolo ko razgradljivih ilnih nosilcev Absorb B...

Страница 133: ...kov smrt MI kakr na koli revaskularizacija TLR TVR NTVR En preiskovanec je uradno prekinil sodelovanje v tudiji po 6 mesecih Pri tem preiskovancu je bila prav tako izvedena revaskularizacija ciljne le...

Страница 134: ...nkov obse nega slikanja Zdravljene lezije so nekoliko kompleksnej e od lezij vklju enih v presku anja pred tudijo ABSORB Dovoljena je obravnava dalj ih lezij z uporabo na rtovanega prekrivanja biolo k...

Страница 135: ...godka sta 1 vazomocija ocenjena glede na spremembo povpre nega premera lumna od pred nitrati in po nitratih pri 3 letih superiornost in 2 minimalni premer lumna pri 3 letih po nitratih minus premer lu...

Страница 136: ...manj na nazivni tlak Na splo no je cilj sprejete prakse za etni tlak pri name anju ki dose e notranji premer nosilca ki je pribli no 1 1 kratnik referen nega premera ile POZOR Ne presezite nazivnega t...

Страница 137: ...eland CUSTOMER SERVICE TEL 800 227 9902 FAX 800 601 8874 Outside USA TEL 951 914 4669 Outside USA FAX 951 914 2531 2015 Abbott MANUFACTURED BY Abbott Vascular Temecula CA 92591 USA EL2103340 4 24 15 P...

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