Evaluation of the GORE TIGRIS Vascular Stent

Peripheral Arterial Disease Clinical Trial

— TIGRIS  

Official title:

Evaluation of the GORE TIGRIS Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576055
• Other study ID #: PCE 09-02
• Status: Completed
• Phase: N/A
• First received: March 29, 2012
• Last updated: September 8, 2017
• Start date: April 2012
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: August 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• TIGRIS Vascular Stent
Implant
• BARD LifeStent
Implant

Locations

Country	Name	City	State
United States	Vascular Surgical Associates, PC	Austell	Georgia
United States	Heritage Valley Health System	Beaver	Pennsylvania
United States	CAMC Health Education and Research Institute, Inc.	Charleston	West Virginia
United States	Northwestern University	Chicago	Illinois
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	Presbyterian Hospital, Dallas	Dallas	Texas
United States	Genesis Medical Center	Davenport	Iowa
United States	Alexian Brothers Specialty Group	Elk Grove Village	Illinois
United States	Kaiser Permanente - Honolulu	Honolulu	Hawaii
United States	Indiana University Vascular Surgery	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	First Coast Cardiovascular Institute, P.A	Jacksonville	Florida
United States	Arkansas Heart	Little Rock	Arkansas
United States	Medical Center of Central Georgia	Macon	Georgia
United States	Minneapolis Radiology and Vascular	Minneapolis	Minnesota
United States	Cardiology Associates of Mobile	Mobile	Alabama
United States	Heart Care Research Foundation	Mokena	Illinois
United States	Vascular Research Institute	Morristown	New Jersey
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	MediQuest Research at Munroe Regional	Ocala	Florida
United States	North County Radiology	Oceanside	California
United States	Orlando Regional Healthcare System	Orlando	Florida
United States	Coastal Vascular & Interventional	Pensacola	Florida
United States	HeartCare MidWest - Peoria	Peoria	Illinois
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Providence Heat & Vascular Institute	Portland	Oregon
United States	The Miriam Hospital	Providence	Rhode Island
United States	UC Davis Vascular Center	Sacramento	California
United States	SSM Health Care	Saint Charles	Missouri
United States	Kaiser Permanente San Francisco	San Francisco	California
United States	North Central Heart Institute, Ltd.	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 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).	30 Days
Primary	Primary Efficacy Endpoint - Number of Participants With Primary Patency at 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.	12 Months
Secondary	Number of Participants With Procedural Success	Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.	Within 48 hours of initial device implant
Secondary	Number of Participants With Device Success	Successful delivery of stent to the intended site and successful stent deployment.	Immediately following initial device implant (usually within a few minutes to an hour).