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

This study has been completed.
Sponsor:
Information provided by:
Cook
ClinicalTrials.gov Identifier:
NCT00196066
First received: September 12, 2005
Last updated: January 30, 2012
Last verified: January 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


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

Publications:
ClinicalTrials.gov Identifier: NCT00196066     History of Changes
Other Study ID Numbers: 02-513
Study First Received: September 12, 2005
Last Updated: January 30, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014