Evaluation of the GORE TIGRIS Vascular Stent (TIGRIS)
|ClinicalTrials.gov Identifier: NCT01576055|
Recruitment Status : Completed
First Posted : April 12, 2012
Results First Posted : October 19, 2016
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: TIGRIS Vascular Stent Device: BARD LifeStent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||267 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: TIGRIS Vascular Stent
GORE TIGRIS Vascular Stent
Device: TIGRIS Vascular Stent
Active Comparator: BARD LifeStent
Device: BARD LifeStent
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576055
Show 34 Study Locations
|Principal Investigator:||John Laird, MD||UC Davis|