Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
267 participants
INTERVENTIONAL
2012-04-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TIGRIS Vascular Stent
GORE TIGRIS Vascular Stent
TIGRIS Vascular Stent
Implant
BARD LifeStent
BARD LifeStent
BARD LifeStent
Implant
Interventions
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TIGRIS Vascular Stent
Implant
BARD LifeStent
Implant
Eligibility Criteria
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Inclusion Criteria
* Abnormal ankle brachial index (ABI ≤0.9).
* At least 21 years of age.
* Reasonable expectation of survival of at least 12 months after the procedure.
* Male, infertile female, or female practicing an effective method of preventing pregnancy.
* One de novo or restenotic lesion of the SFA/PPA with a cumulative length visually estimated to be ≤24cm
* Arteries with reference vessel diameter of 4.0 - 6.5 mm within the SFA/PPA, estimated visually.
* Angiographic evidence of at least one patent tibial artery (\<50% stenosis angiographically).
* Guidewire has successfully traversed the lesion to be treated and is within the true lumen of the distal vessel.
* Lesion has been pre-dilated before stent deployment.
Exclusion Criteria
* Vascular access/catheterization in the target leg within 30 days of study enrollment.
* Prior treatment of the SFA/PPA in the target leg with stenting or bypass.
* Flow-limiting aortoiliac disease.
* Additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented, requiring intervention.
* Arterial aneurysm in the target leg.
* Co-morbid conditions which would preclude compliance with study protocol.
* Obstructive or occlusive non-atherosclerotic disease.
* Creatinine greater than 2.5 mg/dl.
* Amputation above the metatarsals, resulting from vascular disease, in the target leg.
* Septicemia or uncontrolled infection.
* Contraindication to anticoagulation or antiplatelet therapy, including allergy to heparin, or history of heparin induced thrombocytopenia (HIT), or a positive platelet factor 4 (PF4) antibody assay.
* Abnormal platelet levels, i.e., platelet count at Baseline less than 80,000/microliter.
* History of coagulopathy.
21 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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John Laird, MD
Role: PRINCIPAL_INVESTIGATOR
UC Davis
Locations
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Cardiology Associates of Mobile
Mobile, Alabama, United States
Arkansas Heart
Little Rock, Arkansas, United States
North County Radiology
Oceanside, California, United States
UC Davis Vascular Center
Sacramento, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
First Coast Cardiovascular Institute, P.A
Jacksonville, Florida, United States
MediQuest Research at Munroe Regional
Ocala, Florida, United States
Orlando Regional Healthcare System
Orlando, Florida, United States
Coastal Vascular & Interventional
Pensacola, Florida, United States
Vascular Surgical Associates, PC
Austell, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Kaiser Permanente - Honolulu
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Alexian Brothers Specialty Group
Elk Grove Village, Illinois, United States
Heart Care Research Foundation
Mokena, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
HeartCare MidWest - Peoria
Peoria, Illinois, United States
Indiana University Vascular Surgery
Indianapolis, Indiana, United States
Genesis Medical Center
Davenport, Iowa, United States
University of Iowa
Iowa City, Iowa, United States
Minneapolis Radiology and Vascular
Minneapolis, Minnesota, United States
SSM Health Care
Saint Charles, Missouri, United States
Vascular Research Institute
Morristown, New Jersey, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Providence Heat & Vascular Institute
Portland, Oregon, United States
Heritage Valley Health System
Beaver, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
North Central Heart Institute, Ltd.
Sioux Falls, South Dakota, United States
Baylor Research Institute
Dallas, Texas, United States
Presbyterian Hospital, Dallas
Dallas, Texas, United States
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, United States
Countries
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Other Identifiers
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PCE 09-02
Identifier Type: -
Identifier Source: org_study_id