Evaluation of the GORE TIGRIS Vascular Stent

Not Applicable

Completed

Brief Summary: 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).

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months	12 Months	Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.
Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days	30 Days	Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Procedural Success	Within 48 hours of initial device implant	Successful device implantation with a residual stenosis \<30% without acute (within 48 hours) serious adverse events.
Number of Participants With Device Success	Immediately following initial device implant (usually within a few minutes to an hour).	Successful delivery of stent to the intended site and successful stent deployment.

Locations (34): 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
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Cardiology Associates of Mobile
🇺🇸Mobile, Alabama, United States