6
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Ictus / embolism / thrombosis
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Emergency bypass surgery
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Endocarditis
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Allergic reaction to the metals or contrast media
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Coronary artery spasm
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Hemodynamic deterioration
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Arrhythmia
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Aneurysm or pseudo-aneurysm
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Infections
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Total occlusion of the artery / thrombosis / stent embolization
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Reocclusion of the treated area: re-stenosis
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Perforation or dissection of the treated area
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Arteriovenous fistula
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Hypotension/hypertension
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Local haemorrhaging with haematoma at the insertion site
7. How to Use
7.1. Required equipment
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Heparinised normal saline solution
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Contrast medium (use contrast media indicated for intravascular use)
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Proper medical prescription to the procedure
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0.014” guide wire; do not use any other size of guide wire
-
Introducer with haemostatic valve whose size is equal or larger than 5F (except for 4 and 4.5 mm
stent diameters, where 6F is recommended). Do not use smaller sizes as these might damage or
leave useless the catheter
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Guiding catheter
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Haemostatic valve
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Three-way stopcock
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Extension lines
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Inflation device (manual pump with built-in manometer)
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Several standard 10-20cc syringes with saline solution for washing the system.
7.2. System Preparation
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The stent diameter must coincide with the reference vessel diameter, as its length with lesion
length. It is preferably to be a slightly longer to ensure full lesion coating.
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Remove the catheter from the protective dispenser. Check that it is the right size. Remove the
protective pod and stylet from the balloon. Wash the guide lumen with sterile saline solution by
means of injection with a syringe from the tip until it outcomes from the guide wire insertion port.
Do not dry with gauze.
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Inspect the stent to ensure it is located between the radiopaque marks; if it is noted that it has
moved, do not use it.
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Submerge the catheter in sterile saline solution to activate the hydrophilic coating.
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Attach a three-way stopcock to an extension line and the extension line to the luer hub of the deliv-
ery system. Optionally, the inflation pump can be connected to the three-way stopcock.
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Close the air passage through the balloon.
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Attach a 10-20ml syringe with a third part of saline solution to the three-way stopcock.
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Open the three-way stopcock connection between the syringe and the catheter.
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Withdraw the syringe plunger upwards allowing the air bubbles exiting to the liquid (it is recom-
mended that the syringe be in a vertical position).
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When bubbles stop coming in, leave a meniscus of solution in the key and close the three-way
stopcock at the catheter part. Remove the syringe.
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Connect the inflation device with 1/3 of 1:1 contrast medium and saline solution mixture (duly
INSTRUCTIONS FOR USE
CoCr CORONARY STENT SYSTEM
architect
therapies for living
Instrucciones_Architect REV2.indd 6
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