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

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

This study has been completed.

Study NCT00196066. Last updated on September 12, 2005. Information provided by Cook

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary 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.

Condition ^†

Peripheral Arterial Disease (PAD)

Intervention ^†

Device: Peripheral Vessel Stenting

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

150

Start Date ^†

October 2002

Completion Date

April 2006

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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00196066

Organization ID

02-513

Secondary IDs ^††

Study Sponsor ^†

Cook

Collaborators ^††

Investigators ^†

Principal Investigator:

Gerald Zemel, MD

Baptist Cardiac and Vascular Institute

Information Provided By

Cook

Verification Date

September 2005

First Received Date ^†

September 12, 2005

Last Updated Date

September 12, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.