Clinical trial NCT01576055: Evaluation of the GORE TIGRIS Vascular Stent
Official title: Evaluation of the GORE TIGRIS Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Superficial Femoral Artery
Proximal Popliteal Artery
PAD
SFA
PPA
Stent
Gore
Bare Metal Stent
LifeStent
atherosclerosis
Heparin
claudication
leg pain
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2012-04-12
Enrollment: 267
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 outcomes:
measure: Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days
timeFrame: 30 Days
measure: Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months
timeFrame: 12 Months
Secondary outcomes:
measure: Number of Participants With Procedural Success
timeFrame: Within 48 hours of initial device implant
measure: Number of Participants With Device Success
timeFrame: Immediately following initial device implant (usually within a few minutes to an hour).
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Cardiology Associates of Mobile
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Heart
state: Arkansas
city: Oceanside
country: United States
facility: North County Radiology
state: California
city: Sacramento
country: United States
facility: UC Davis Vascular Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute, P.A
state: Florida
city: Ocala
country: United States
facility: MediQuest Research at Munroe Regional
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Healthcare System
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular & Interventional
state: Florida
city: Austell
country: United States
facility: Vascular Surgical Associates, PC
state: Georgia
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente - Honolulu
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Specialty Group
state: Illinois
city: Mokena
country: United States
facility: Heart Care Research Foundation
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Peoria
country: United States
facility: HeartCare MidWest - Peoria
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Vascular Surgery
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Minneapolis
country: United States
facility: Minneapolis Radiology and Vascular
state: Minnesota
city: Saint Charles
country: United States
facility: SSM Health Care
state: Missouri
city: Morristown
country: United States
facility: Vascular Research Institute
state: New Jersey
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Portland
country: United States
facility: Providence Heat & Vascular Institute
state: Oregon
city: Beaver
country: United States
facility: Heritage Valley Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Sioux Falls
country: United States
facility: North Central Heart Institute, Ltd.
state: South Dakota
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Dallas
country: United States
facility: Presbyterian Hospital, Dallas
state: Texas
city: Charleston
country: United States
facility: CAMC Health Education and Research Institute, Inc.
state: West Virginia
Study officials:
affiliation: UC Davis
name: John Laird, MD
role: PRINCIPAL_INVESTIGATOR
References: