COOK Medical Zilver Mode D'emploi page 8

• Ischemia requiring intervention (bypass or amputation of toe, foot
or leg)
• Myocardial infarction (MI)
• Pseudoaneurysm formation
• Pulmonary embolism
• Renal failure
• Restenosis of the stented artery
• Septicemia/bacteremia
• Stent malapposition
• Stent migration
• Stent strut fracture
• Stroke
• Spasm
• Tissue necrosis
• Worsened claudication/rest pain
SUMMARY OF CLINICAL INVESTIGATIONS
A pilot study of the safety of the Zilver Vascular Stent enrolled 20 patients at four investigative
sites and provided justification for initiation of a pivotal study to assess the safety and
effectiveness of the Zilver Vascular Stent.
A total of 151 patients at 24 U.S. investigative sites were enrolled in a pivotal study to evaluate
the safety and effectiveness of the Zilver Vascular Stent for use as an adjunct to percutaneous
transluminal angioplasty (PTA) in the treatment of symptomatic vascular disease of the iliac
arteries. The following is a summary of the pivotal study.
Study Endpoints
This prospective, non-randomized study of the Zilver Vascular Stent for the treatment of
stenotic or occlusive lesions of the external or common iliac arteries was intended to establish
the rate of major adverse events (MAE) at 9-month clinical follow-up as the primary study
endpoint compared to an Objective Performance Criterion (OPC) derived from literature
of recent studies in similar patient populations. The MAE rate of the OPC was set to be not
greater than 16%, with a 9% delta. Secondary endpoints included acute procedure success,
30-day clinical success, 9-month patency rate based on ultrasound examination, ankle-
brachial index, and 9-month functional status as measured by the walking impairment
questionnaire.
Patient Population
Patients eligible to enroll in this study had up to two documented stenotic (≤10 cm long) or
occluded (≤5 cm long) atherosclerotic lesions of the external iliac or common iliac artery on
opposite sides. Lesions could be either de novo or restenotic. Patients with previously stented
lesions were excluded. Characteristics of the patients enrolled in this study, including age,
gender, medical history as well as angiographic characteristics of the treated lesions (pre-
procedure), are included in Tables 2 and 3.
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