NCT02772224

Efficacy and Safety of Paclitaxel-eluting Balloons for Below the Knee Peripheral Arterial Disease

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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Drug eluting balloon angioplasty	In the DEB group, the guide wire will be passed through the occluded or stenosed lumen and the predilatation of the target lesion with standard balloon(s) will be performed before dilatation with a paclitaxel-eluting balloon of the diameter, at least about that of the pre-dilatation balloon (Arteryguard, Rientech, Dezhou, China). The drug eluting balloons will then be inflated according to the manufacturer recommendations. The patients will then be followed every six months for a year to compare its treatment efficacy and safety with that of conventional balloon angioplasty group.
DEVICE	Conventional balloon angioplasty	The guide wire will be passed through the occluded or stenosed lumen and the conventional balloons will be inflated as recommended by the manufacturer. The primary and secondary outcome will then be assessed and compared with DEB group, on follow up at six and 12 months.

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-09-01
• Completion: 2017-09-01
• First posted: 2016-05-13
• Last updated: 2016-05-13

Locations

1 site across 1 country: China