NCT00712309

Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Herz-Zentrums Bad Krozingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Popliteal Artery

Interventions

Type	Name	Description
DEVICE	Lifestent	Stent for endovascular treatment of popliteal artery lesions
DEVICE	balloon-angioplasty (PTA)	PTA for endovascular treatment of popliteal artery lesions

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-06-01
• First posted: 2008-07-09
• Last updated: 2009-02-10

Locations

2 sites across 1 country: Germany