NCT00673985

Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Intermittent Claudication
• Atherosclerotic Disease
• Arterial Occlusive Disease

Interventions

Type	Name	Description
OTHER	Percutaneous Transluminal Angioplasty	Balloon Angioplasty
DEVICE	LifeStent NT™ Self-Expanding Peripheral Stent	Balloon angioplasty plus stent

Timeline

• Start date: 2004-07-01
• Primary completion: 2006-08-01
• Completion: 2010-10-01
• First posted: 2008-05-07
• Last updated: 2017-07-14