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Evaluation of the GORE TIGRIS Vascular Stent (TIGRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01576055
Recruitment Status : Completed
First Posted : April 12, 2012
Results First Posted : October 19, 2016
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Description
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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).

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: TIGRIS Vascular Stent Device: BARD LifeStent Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the GORE TIGRIS Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal Arteries
Study Start Date : April 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TIGRIS Vascular Stent
GORE TIGRIS Vascular Stent
 Device: TIGRIS Vascular Stent
Implant
Active Comparator: BARD LifeStent
BARD LifeStent
 Device: BARD LifeStent
Implant


Outcome Measures
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Primary Outcome Measures :
  1. Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days [ Time Frame: 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).

  2. Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months [ Time Frame: 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 :
  1. Number of Participants With Procedural Success [ Time Frame: Within 48 hours of initial device implant ]
    Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.

  2. Number of Participants With Device Success [ Time Frame: Immediately following initial device implant (usually within a few minutes to an hour). ]
    Successful delivery of stent to the intended site and successful stent deployment.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576055


Locations
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Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: John Laird, MD UC Davis
More Information
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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01576055    
Other Study ID Numbers: PCE 09-02
First Posted: April 12, 2012    Key Record Dates
Results First Posted: October 19, 2016
Last Update Posted: October 9, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by W.L.Gore & Associates:
Peripheral Arterial Disease
Superficial Femoral Artery
Proximal Popliteal Artery
PAD
SFA
PPA
Stent
 Gore
Bare Metal Stent
LifeStent
atherosclerosis
Heparin
claudication
leg pain
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases