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Evaluation of the GORE TIGRIS Vascular Stent (TIGRIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01576055
First Posted: April 12, 2012
Last Update Posted: October 9, 2017
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.
Information provided by (Responsible Party):
W.L.Gore & Associates
March 29, 2012
April 12, 2012
August 24, 2016
October 19, 2016
October 9, 2017
April 2012
August 2015   (Final data collection date for primary outcome measure)
  • 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).
  • 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.
Not Provided
Complete list of historical versions of study NCT01576055 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
Not Provided
 
Evaluation of the GORE TIGRIS Vascular Stent
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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peripheral Arterial Disease
  • Device: TIGRIS Vascular Stent
    Implant
  • Device: BARD LifeStent
    Implant
  • Experimental: TIGRIS Vascular Stent
    GORE TIGRIS Vascular Stent
    Intervention: Device: TIGRIS Vascular Stent
  • Active Comparator: BARD LifeStent
    BARD LifeStent
    Intervention: Device: BARD LifeStent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
267
August 2017
August 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01576055
PCE 09-02
Yes
Not Provided
Plan to Share IPD: No
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: John Laird, MD UC Davis
W.L.Gore & Associates
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP