Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)

Cook Group Incorporated0 sites150 target enrollmentOctober 2002

ConditionsPeripheral Arterial Disease (PAD)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Peripheral Arterial Disease (PAD)
Sponsor: Cook Group Incorporated
Enrollment: 150
Primary Endpoint: The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

April 2006

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cook Group Incorporated

Eligibility Criteria

Inclusion Criteria

•Patient has documented stenotic or occluded atherosclerotic lesions of the external iliac or common iliac artery.
•Patient has a de novo or restenotic lesion(s) with no prior stent in the target lesion.
•Patient has given informed consent.

Exclusion Criteria

•Patient is less than 50 years of age
•Patient is participating in another investigational drug or device study.
•Patient has multiple lesions (ipsilateral or in the aorta) that would require a staged procedure.
•Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
•Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, nitinol, or contrast dye that cannot be adequately premedicated.
•Patient is pregnant or breast-feeding.

Outcomes

Primary Outcomes

The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.

Secondary Outcomes

Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement.