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Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study — RESILIENT  

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

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00673985
Study type Interventional
Source C. R. Bard
Contact
Status Completed
Phase N/A
Start date July 2004
Completion date October 2010
View Details
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