Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices. The stent self-expands once inside the artery where it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow over the stent helping to hold it in place.
Peripheral Arterial Disease (PAD)
Device: Peripheral Vessel Stenting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
- The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.
- Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement.
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||April 2006|