Evaluation of the GORE TIGRIS Vascular Stent

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).

Key facts

Study ID

NCT01576055

Run by

W.L.Gore & Associates

People needed

267

Starts

2012-04-01

Expected to finish

2017-08-01

Last updated by the study team

2017-10-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Rutherford Class 2 - 4.
• 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.

You may not qualify if…

• Prior enrollment in this study.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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