COOK Medical Zilver Mode D'emploi page 9

Table 2: Characteristics of Patients Implanted with the Zilver Vascular Stent
Baseline Characteristics
Age (Mean years +/- SD)
Male Gender
Smoking Status
Diabetes
Hypercholesterolemia
Hypertension
Carotid Disease
Renal Disease
Pulmonary Disease
Use of Antiplatelets
CHF Class 3 or 4
Previous MI
Table 3: Angiographic Characteristics of the Lesions Prior to Treatment with the Zilver
Vascular Stent
Angiographic Characteristics
Lesion Length (mm)
RVD (mm)
In-Stent MLD (mm)
% Diameter In-Stent Stenosis
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
Past
Current
109
117
116
Lesions
(N=177)
168
171
171
171
9
Patients
(N=151)
67 ± 8.9
93 61.6%
79 52.3%
65 43.0%
46 30.5%
72.2%
77.5%
49 32.5%
23 15.2%
50 33.1%
76.8%
7 4.6%
47 31.1%
Mean ± S.D.
32.9 ± 18.8
7.4 ± 1.5
2.7 ± 1.4
64.5 ± 15.2