Atherosclerosis Clinical Trial
Official title:
Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
The purpose of this study to compare balloon angioplasty (PTA) vs. cutting balloon angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral artery disease.
Balloon Angioplasty is a minimal invasive technique for treatment of superficial
femoropoliteal artery obstructions. Despite high initial success rate and an acceptably low
complication rate, long-term-results are disappointing as restenosis may frequently occur.
One of the hypothesis for the differences in the reported patency rates is that the amount
of vessel trauma correlates directly to the prognosis (restenosis) of the treated vessel
wall segment.
With the introduction of cutting balloons the problems of elastic recoil and residual
stenosis might be resolved, by reduction of vessel wall trauma, vessel wall inflammation and
consequently reduced neointima formation.
The promising results especially in coronary arteries led us to initiate a RCT comparing
primary PTA vs. CB-PTA for treatment of femoropoliteal obstructions in patients with
intermittent claudication or critical limb ischemia.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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