Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study (RESILIENT)
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|ClinicalTrials.gov Identifier: NCT00673985|
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intermittent Claudication Atherosclerotic Disease Arterial Occlusive Disease||Other: Percutaneous Transluminal Angioplasty Device: LifeStent NT™ Self-Expanding Peripheral Stent||Not Applicable|
The RESILIENT Trial is a dual stage clinical investigation designed to evaluate the safety and effectiveness of the Edwards Lifesciences self-expanding stent system.
Phase 1 consists of a prospective, multi-center, non-randomized study with a peri-procedure endpoint. Phase 2 consists of a prospective, multi-center, randomized study with a 30-day primary safety endpoint and a 6-month primary effectiveness endpoint.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||246 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||October 2010|
Active Comparator: 1
PTA Only: Active Comparator
Percutaneous transluminal angioplasty (PTA) alone
Other: Percutaneous Transluminal Angioplasty
Test Arm: Experimental
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease.
Device: LifeStent NT™ Self-Expanding Peripheral Stent
Balloon angioplasty plus stent
- Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. [ Time Frame: 30 Day, 6 Month, and 12 Month ]
- Safety: Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel at 30-days post-procedure. Freedom from 30-day death and 6-month [ Time Frame: 30 Day, 6 Month and12 Month ]
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): NCT00673985
|Principal Investigator:||Barry T Katzen, MD||Baptist Cardiac & Vascular Institute, Miami, FL|
|Principal Investigator:||John R Laird, MD||Vascular Center at the University of California, Davis Medical Center|