Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting

13:11 EDT 31st October 2014 | BioPortfolio

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?

Study Design

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

Conditions

Popliteal Artery

Intervention

Lifestent, balloon-angioplasty (PTA)

Location

Herzzentrum Bad Krozingen
Bad Krozingen
Germany
79189

Status

Recruiting

Source

Herz-Zentrums Bad Krozingen

Results (where available)

View Results

Links

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Medical and Biotech [MESH] Definitions

Use of a balloon catheter for dilatation of an occluded artery. It is used in treatment of arterial occlusive diseases, including renal artery stenosis and arterial occlusions in the leg. For the specific technique of balloon dilatation in coronary arteries, ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY is available.

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