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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196066
First Posted: September 20, 2005
Last Update Posted: February 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cook Group Incorporated
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)

Further study details as provided by Cook Group Incorporated:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196066


Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Gerald Zemel, MD Baptist Cardiac and Vascular Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00196066     History of Changes
Other Study ID Numbers: 02-513
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: February 1, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases