Back to resultsEvaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
Primary Purpose
Peripheral Arterial Disease (PAD)
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Peripheral Vessel Stenting
Sponsored by
About this trial
This is an interventional other trial for Peripheral Arterial Disease (PAD)
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.
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00196066
First Posted
September 12, 2005
Last Updated
May 9, 2023
Sponsor
Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00196066
Brief Title
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease (PAD)
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Peripheral Vessel Stenting
Primary Outcome Measure Information:
Title
The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.
Secondary Outcome Measure Information:
Title
Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Zemel, MD
Organizational Affiliation
Baptist Cardiac and Vascular Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
18192463
Citation
Krol KL, Saxon RR, Farhat N, Botti CF, Brown OW, Zemel G, Raabe RD, Voorhees WD 3rd, Katzen BT. Clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease. J Vasc Interv Radiol. 2008 Jan;19(1):15-22. doi: 10.1016/j.jvir.2007.08.031.
Results Reference
background
PubMed Identifier
20801673
Citation
Jaff MR, Katzen BT. Two-year clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease. J Vasc Interv Radiol. 2010 Oct;21(10):1489-94. doi: 10.1016/j.jvir.2010.06.013.
Results Reference
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Learn more about this trial
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
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