Intermittent Claudication Clinical Trial
Official title:
A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter
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 by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone
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.
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