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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: August 24, 2016
Last verified: August 2016

March 29, 2012
August 24, 2016
April 2012
August 2015   (final data collection date for primary outcome measure)
  • Primary Safety Endpoint - Major Adverse Events [ 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 - Primary Patency [ 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.
Not Provided
Complete list of historical versions of study NCT01576055 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Arterial Disease
  • Device: TIGRIS Vascular Stent
    Implant
  • Device: BARD
    Implant
  • Experimental: TIGRIS Vascular Stent
    Intervention: Device: TIGRIS Vascular Stent
  • Active Comparator: BARD(r) LifeStent
    Intervention: Device: BARD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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 PF4 (platelet factor 4) antibody assay.
  • Abnormal platelet levels, i.e., platelet count at Baseline less than 80,000/microliter.
  • History of coagulopathy.
Both
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
No
Not Provided
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: John Laird, MD UC Davis
W.L.Gore & Associates
August 2016

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