Status and phase
Conditions
Treatments
About
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).
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
180 participants in 2 patient groups
Loading...
Central trial contact
Maoquan Li, Ph.D
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal