COOK Medical Zilver, Инструкция по эксплуатации

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Table 2: Characteristics of Patients Implanted with the Zilver Vascular Stent
Baseline Characteristics
Patients
(N=151)
Age (Mean years +/- SD) 67 ± 8.9
Male Gender 93 61.6%
Smoking Status
Past 79 52.3%
Current 65 43.0%
Diabetes 46 30.5%
Hypercholesterolemia 109 72.2%
Hypertension 117 77.5%
Carotid Disease 49 32.5%
Renal Disease 23 15.2%
Pulmonary Disease 50 33.1%
Use of Antiplatelets 116 76.8%
CHF Class 3 or 4 7 4.6%
Previous MI 47 31.1%
Table 3: Angiographic Characteristics of the Lesions Prior to Treatment with the Zilver
Vascular Stent
Angiographic Characteristics
Lesions
(N=177) Mean ± S.D.
Lesion Length (mm) 168 32.9 ± 18.8
RVD (mm) 171 7.4 ± 1.5
In-Stent MLD (mm) 171 2.7 ± 1.4
% Diameter In-Stent Stenosis 171 64.5 ± 15.2
Methods
All patients underwent PTA (predilatation) of the target lesion prior to deployment of the
stent. Up to two lesions per patient on opposite sides were stented with no more than
two stents per lesion. Patients had an angiogram prior to and immediately following stent
placement. Duplex ultrasound to assess patency of the stented artery and common femoral
artery was performed no more than three days following the procedure. The protocol
recommended each hospital follow its standard protocol with respect to pre- and post-
procedure medication; based on previous published studies, clopidogrel was suggested
before and post-procedure for 6 months. Patients underwent clinical follow-up at 1 and
9 months post-procedure. Clinical follow-up at 1 month included measurement of ABI on
the treated side as well as completion of a walking impairment questionnaire. Follow-up