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Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
This study has been completed.
Study NCT00196066   Information provided by Cook
First Received: September 12, 2005   No Changes Posted

September 12, 2005
September 12, 2005
October 2002
 
The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.
Same as current
No Changes Posted
Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement.
Same as current
 
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
 

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.

 
Phase II
Interventional
Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Peripheral Arterial Disease (PAD)
Device: Peripheral Vessel Stenting
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
150
April 2006
 

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00196066
 
02-513
Cook
 
Principal Investigator: Gerald Zemel, MD Baptist Cardiac and Vascular Institute
Cook
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP