Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting — ETAP  

Popliteal Artery Clinical Trial

Official title: Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting

Status Recruiting

Clinical Trial Summary

1. Does primary stenting have a lower 12-month restenosis rate than PTA alone in the treatment of atherosclerotic lesions of the popliteal artery?

• Alternative hypothesis: "Primary stenting with the Edwards LifeStent is associated with a lower restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery at 12 months"

• Null hypothesis: "Primary stenting with the Edwards LifeStent is not associated with a lower 12-month restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery""

2. Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints?

3. How do the intervention methods compare in terms of safety/incidence of adverse effects?

4. What are the long-term clinical implications of the two treatment methods?

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Popliteal Artery

• NCT number: NCT00712309
• Study type: Interventional
• Source: Herz-Zentrums Bad Krozingen
• Contact: Thomas Zeller, MD
• Phone: 004976334024350
• Email: thomas.zeller@herzzentrum.de
• Status: Recruiting
• Phase: N/A
• Start date: February 2007