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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014