Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Peripheral Arterial Disease (PAD)	Device: Peripheral Vessel Stenting	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Cook:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	October 2002
Estimated Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196066

Sponsors and Collaborators

Cook

Investigators


Principal Investigator:	Gerald Zemel, MD	Baptist Cardiac and Vascular Institute

More Information

Study ID Numbers:	02-513
First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00196066
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Peripheral Vascular Diseases

Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Cook
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00196066