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Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting

2010-07-15 12:00:00 | 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

Published on BioPortfolio: 2010-07-15T12:00:00-0400

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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.

Techniques using laser energy in combination with a balloon catheter to perform angioplasty. These procedures can take several forms including: 1, laser fiber delivering the energy while the inflated balloon centers the fiber and occludes the blood flow; 2, balloon angioplasty immediately following laser angioplasty; or 3, laser energy transmitted through angioplasty balloons that contain an internal fiber.

A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).

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