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

Tongji University

Status and phase: Unknown; Phase 1

Conditions: Peripheral Arterial Disease

Treatments: Device: Drug eluting balloon angioplasty; Device: Conventional balloon angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02772224

425008534

Details and patient eligibility

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: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with Peripheral vascular disease with or without diabetes.
2. Rutherford class 2-6.
3. Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.
4. Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.
5. Written informed consent signed by the patients or representatives

Exclusion criteria

1. Previous bypass surgery or stent placement at the ipsilateral lower limb
2. History of intolerance to antiplatelet therapy, heparin, or contrast media.
3. Bleeding diathesis;
4. Active systemic bacterial infection;
5. Severely impaired renal function (serum creatinine level > 2.5 mg/dL.
6. Expected survival time of less than 24 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Drug eluting balloon angioplasty

Experimental group

Description:

Paclitaxel coated balloon angioplasty

Treatment:

Device: Drug eluting balloon angioplasty

Conventional balloon angioplasty

Active Comparator group

Description:

Conventional balloon angioplasty

Treatment:

Device: Conventional balloon angioplasty