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.
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Restenosis rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Peripheral vascular disease with or without diabetes.
- •Rutherford class 2-
- •Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.
- •Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.
- •Written informed consent signed by the patients or representatives
Exclusion Criteria
- •Previous bypass surgery or stent placement at the ipsilateral lower limb
- •History of intolerance to antiplatelet therapy, heparin, or contrast media.
- •Bleeding diathesis;
- •Active systemic bacterial infection;
- •Severely impaired renal function (serum creatinine level > 2.5 mg/dL.
- •Expected survival time of less than 24 months
Arms & Interventions
Conventional balloon angioplasty
Conventional balloon angioplasty
Intervention: Conventional balloon angioplasty (Device)
Drug eluting balloon angioplasty
Paclitaxel coated balloon angioplasty
Intervention: Drug eluting balloon angioplasty (Device)
Outcomes
Primary Outcomes
Restenosis rate
Time Frame: 12 months
The primary study endpoint was the occurrence of \> 50% of restenosis in the treated vessel after 12 months as assessed by digital substraction angiography (DSA).
Peak systolic velocity ratio
Time Frame: 12 months
Peak systolic velocity ratio ≥ 2.4 by Doppler's ultrasonography was the end point of the study for the patient who did not undergo angiography after 12 months.
Secondary Outcomes
- Rutherford scale(Immediately after procedure)
- ABI value(Immediately after procedure)
- Residual stenosis(Immediately after procedure)
Investigators
Maoquan Li
Prof. Dr.Li
Shanghai 10th People's Hospital