Evaluation of the GORE TIGRIS Vascular Stent
TIGRIS
1 other identifier
interventional
267
1 country
34
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
April 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedResults Posted
Study results publicly available
October 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedOctober 9, 2017
September 1, 2017
3.3 years
March 29, 2012
August 24, 2016
September 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 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 Outcomes (2)
Number of Participants With Procedural Success
Within 48 hours of initial device implant
Number of Participants With Device Success
Immediately following initial device implant (usually within a few minutes to an hour).
Study Arms (2)
TIGRIS Vascular Stent
EXPERIMENTALGORE TIGRIS Vascular Stent
BARD LifeStent
ACTIVE COMPARATORBARD LifeStent
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Cardiology Associates of Mobile
Mobile, Alabama, 36532, United States
Arkansas Heart
Little Rock, Arkansas, 72211, United States
North County Radiology
Oceanside, California, 92056, United States
UC Davis Vascular Center
Sacramento, California, 95817, United States
Kaiser Permanente San Francisco
San Francisco, California, 94118, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
First Coast Cardiovascular Institute, P.A
Jacksonville, Florida, 32216, United States
MediQuest Research at Munroe Regional
Ocala, Florida, 34471, United States
Orlando Regional Healthcare System
Orlando, Florida, 32806, United States
Coastal Vascular & Interventional
Pensacola, Florida, 32504, United States
Vascular Surgical Associates, PC
Austell, Georgia, 30106, United States
Medical Center of Central Georgia
Macon, Georgia, 31201, United States
Kaiser Permanente - Honolulu
Honolulu, Hawaii, 96817, United States
Northwestern University
Chicago, Illinois, 60611, United States
Alexian Brothers Specialty Group
Elk Grove Village, Illinois, 60007, United States
Heart Care Research Foundation
Mokena, Illinois, 60448, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
HeartCare MidWest - Peoria
Peoria, Illinois, 61614, United States
Indiana University Vascular Surgery
Indianapolis, Indiana, 46202, United States
Genesis Medical Center
Davenport, Iowa, 52803, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Minneapolis Radiology and Vascular
Minneapolis, Minnesota, 55441, United States
SSM Health Care
Saint Charles, Missouri, 63301, United States
Vascular Research Institute
Morristown, New Jersey, 07960, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Providence Heat & Vascular Institute
Portland, Oregon, 97225, United States
Heritage Valley Health System
Beaver, Pennsylvania, 15009, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
North Central Heart Institute, Ltd.
Sioux Falls, South Dakota, 57108, United States
Baylor Research Institute
Dallas, Texas, 75093, United States
Presbyterian Hospital, Dallas
Dallas, Texas, 75231, United States
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, 25304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Sabin
- Organization
- W.L. Gore & Associates
Study Officials
- PRINCIPAL INVESTIGATOR
John Laird, MD
UC Davis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2012
First Posted
April 12, 2012
Study Start
April 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2017
Last Updated
October 9, 2017
Results First Posted
October 19, 2016
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share