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Evaluation of the GORE TIGRIS Vascular Stent (TIGRIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01576055
First received: March 29, 2012
Last updated: October 24, 2016
Last verified: October 2016
  Purpose
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 Intervention
Peripheral Arterial Disease
Device: TIGRIS Vascular Stent
Device: BARD LifeStent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 48 hours of initial device implant ] [ Designated as safety issue: No ]
    Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.

  • Number of Participants With Device Success [ Time Frame: Immediately following initial device implant (usually within a few minutes to an hour). ] [ Designated as safety issue: No ]
    Successful delivery of stent to the intended site and successful stent deployment.


Enrollment: 267
Study Start Date: April 2012
Estimated Study Completion Date: August 2017
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TIGRIS Vascular Stent
GORE TIGRIS Vascular Stent
Device: TIGRIS Vascular Stent
Implant
Active Comparator: BARD LifeStent
BARD LifeStent
Device: BARD LifeStent
Implant

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576055

  Show 34 Study Locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: John Laird, MD UC Davis
  More Information

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01576055     History of Changes
Other Study ID Numbers: PCE 09-02 
Study First Received: March 29, 2012
Results First Received: August 24, 2016
Last Updated: October 24, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 08, 2016