Peripheral Arterial Disease Clinical Trial
Official title:
The Efficacy and Safety of Paclitaxel-eluting Balloons for the Treatment of Below the Knee Peripheral Arterial Disease as Compared to Conventional Balloon Angioplasty: a Randomized Controlled Clinical Trial.
Comparing the efficacy and safety of drug-eluting balloons (DEB) for the treatment of below-the-knee peripheral arterial occlusive disease with conventional balloon angioplasty (BA).
Over the past decade, percutaneous transluminal angioplasty (PTA) has established its
position in the treatment of below the knee arterial occlusive disease with intermittent
claudication and/or critical limb ischemia. However, the efficacy of percutaneous
transluminal angioplasty (PTA) with conventional balloons, is limited by the high 12-month
restenosis and target lesion revascularization (TLR) rates. Local delivery of newer
anti-proliferative drug via drug-eluting balloons (DEBs) has recently shown promising
results in the treatment of femoropopliteal disease, and in the BTK area, a reduction in
3-month binary restenosis has been observed compared with historical controls treated with
PTA. Drug eluting balloon has three potential advantages: (1) homogenous drug transfer to
the vessel wall; (2) highest drug concentrations at the vessel wall at the time of injury;
and (3) absence of a stent or delivery polymer.
This study sought to investigate the long-term efficacy and safety of new drug
(Paclitaxel)-eluting balloons (DEB) for the treatment of below the knee peripheral arterial
disease.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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