Evaluation of the GORE TIGRIS Vascular Stent (TIGRIS)

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

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: TIGRIS Vascular Stent; Device: BARD LifeStent

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36532
      • Cardiology Associates of Mobile
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart
  • California
    • Oceanside, California, United States, 92056
      • North County Radiology
    • Sacramento, California, United States, 95817
      • UC Davis Vascular Center
    • San Francisco, California, United States, 94118
      • Kaiser Permanente San Francisco
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
  • Florida
    • Jacksonville, Florida, United States, 32216
      • First Coast Cardiovascular Institute, P.A
    • Ocala, Florida, United States, 34471
      • MediQuest Research at Munroe Regional
    • Orlando, Florida, United States, 32806
      • Orlando Regional Healthcare System
    • Pensacola, Florida, United States, 32504
      • Coastal Vascular & Interventional
  • Georgia
    • Austell, Georgia, United States, 30106
      • Vascular Surgical Associates, PC
    • Macon, Georgia, United States, 31201
      • Medical Center of Central Georgia
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Kaiser Permanente - Honolulu
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Specialty Group
    • Mokena, Illinois, United States, 60448
      • Heart Care Research Foundation
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
    • Peoria, Illinois, United States, 61614
      • HeartCare MidWest - Peoria
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Vascular Surgery
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Genesis Medical Center
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Minnesota
    • Minneapolis, Minnesota, United States, 55441
      • Minneapolis Radiology and Vascular
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • SSM Health Care
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Vascular Research Institute
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heat & Vascular Institute
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Health System
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart Institute, Ltd.
  • Texas
    • Dallas, Texas, United States, 75093
      • Baylor Research Institute
    • Dallas, Texas, United States, 75231
      • Presbyterian Hospital, Dallas
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Health Education and Research Institute, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIGRIS Vascular Stent; GORE TIGRIS Vascular Stent	Device: TIGRIS Vascular Stent; Implant
Active Comparator: BARD LifeStent	Device: BARD LifeStent; Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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).

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: John Laird, MD, UC Davis

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: April 10, 2012
• First Posted (Estimate): April 12, 2012

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: PAD; Stent; Gore; atherosclerosis; leg pain; Heparin; Bare Metal Stent; claudication; Peripheral Arterial Disease; SFA; Superficial Femoral Artery; PPA; Proximal Popliteal Artery; LifeStent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: PCE 09-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No