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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease (PAD)
• Intervention / Treatment: Device: Peripheral Vessel Stenting

• Study Type: Interventional
• Enrollment: 150
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cook Group Incorporated
• Investigators: Principal Investigator: Gerald Zemel, MD, Baptist Cardiac and Vascular Institute

Publications and helpful links

General Publications

• Krol KL, Saxon RR, Farhat N, Botti CF, Brown OW, Zemel G, Raabe RD, Voorhees WD 3rd, Katzen BT. Clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease. J Vasc Interv Radiol. 2008 Jan;19(1):15-22. doi: 10.1016/j.jvir.2007.08.031.
• Jaff MR, Katzen BT. Two-year clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease. J Vasc Interv Radiol. 2010 Oct;21(10):1489-94. doi: 10.1016/j.jvir.2010.06.013.

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Study Completion: April 1, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 02-513