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

NCT00196066 | Completed Phase 2

• 1 other identifier: 02-513
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Arterial Disease (PAD)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Peripheral Vessel Stenting DEVICE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook Group Incorporated: lead

Related Publications (2)

• 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.

  PMID: 18192463 BACKGROUND

• 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.

  PMID: 20801673 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Gerald Zemel, MD

  Baptist Cardiac and Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 2002
• Study Completion: April 1, 2006
• Last Updated: May 10, 2023

Record last verified: 2023-05