search
Back to results

Evaluation of the GORE TIGRIS Vascular Stent (TIGRIS)

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TIGRIS Vascular Stent
BARD LifeStent
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Superficial Femoral Artery, Proximal Popliteal Artery, PAD, SFA, PPA, Stent, Gore, Bare Metal Stent, LifeStent, atherosclerosis, Heparin, claudication, leg pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiology Associates of Mobile
  • Arkansas Heart
  • North County Radiology
  • UC Davis Vascular Center
  • Kaiser Permanente San Francisco
  • Yale University School of Medicine
  • First Coast Cardiovascular Institute, P.A
  • MediQuest Research at Munroe Regional
  • Orlando Regional Healthcare System
  • Coastal Vascular & Interventional
  • Vascular Surgical Associates, PC
  • Medical Center of Central Georgia
  • Kaiser Permanente - Honolulu
  • Northwestern University
  • Alexian Brothers Specialty Group
  • Heart Care Research Foundation
  • Advocate Christ Medical Center
  • HeartCare MidWest - Peoria
  • Indiana University Vascular Surgery
  • Genesis Medical Center
  • University of Iowa
  • Minneapolis Radiology and Vascular
  • SSM Health Care
  • Vascular Research Institute
  • Ohio Health Research Institute
  • Providence Heat & Vascular Institute
  • Heritage Valley Health System
  • University of Pennsylvania
  • University of Pittsburgh Medical Center
  • The Miriam Hospital
  • North Central Heart Institute, Ltd.
  • Baylor Research Institute
  • Presbyterian Hospital, Dallas
  • CAMC Health Education and Research Institute, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIGRIS Vascular Stent

BARD LifeStent

Arm Description

GORE TIGRIS Vascular Stent

BARD LifeStent

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Number of Participants With Procedural Success
Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.
Number of Participants With Device Success
Successful delivery of stent to the intended site and successful stent deployment.

Full Information

First Posted
March 29, 2012
Last Updated
September 8, 2017
Sponsor
W.L.Gore & Associates
search

1. Study Identification

Unique Protocol Identification Number
NCT01576055
Brief Title
Evaluation of the GORE TIGRIS Vascular Stent
Acronym
TIGRIS
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIGRIS Vascular Stent
Arm Type
Experimental
Arm Description
GORE TIGRIS Vascular Stent
Arm Title
BARD LifeStent
Arm Type
Active Comparator
Arm Description
BARD LifeStent
Intervention Type
Device
Intervention Name(s)
TIGRIS Vascular Stent
Intervention Description
Implant
Intervention Type
Device
Intervention Name(s)
BARD LifeStent
Intervention Description
Implant
Primary Outcome Measure Information:
Title
Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days
Description
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).
Time Frame
30 Days
Title
Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months
Description
Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Number of Participants With Procedural Success
Description
Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.
Time Frame
Within 48 hours of initial device implant
Title
Number of Participants With Device Success
Description
Successful delivery of stent to the intended site and successful stent deployment.
Time Frame
Immediately following initial device implant (usually within a few minutes to an hour).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Laird, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Associates of Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Arkansas Heart
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
North County Radiology
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
UC Davis Vascular Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
First Coast Cardiovascular Institute, P.A
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
MediQuest Research at Munroe Regional
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Orlando Regional Healthcare System
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Coastal Vascular & Interventional
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Vascular Surgical Associates, PC
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Kaiser Permanente - Honolulu
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Alexian Brothers Specialty Group
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Heart Care Research Foundation
City
Mokena
State/Province
Illinois
ZIP/Postal Code
60448
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
HeartCare MidWest - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Indiana University Vascular Surgery
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Minneapolis Radiology and Vascular
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
SSM Health Care
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Vascular Research Institute
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Providence Heat & Vascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Heritage Valley Health System
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
North Central Heart Institute, Ltd.
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Presbyterian Hospital, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
CAMC Health Education and Research Institute, Inc.
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the GORE TIGRIS Vascular Stent

We'll reach out to this number within 24 hrs