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

Phase 1

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Conventional balloon angioplasty; Device: Drug eluting balloon angioplasty

• Registration Number: NCT02772224
• Lead Sponsor: Shanghai 10th People's Hospital

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 Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-08
• Study First Submitted QC: 2016-05-11
• Last Update Submitted: 2016-05-11
• Study First Posted: 2016-05-13
• Last Update Posted: 2016-05-13
• Study Start: 2016-06
• Primary Completion: 2016-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional balloon angioplasty	Conventional balloon angioplasty	Conventional balloon angioplasty
Drug eluting balloon angioplasty	Drug eluting balloon angioplasty	Paclitaxel coated balloon angioplasty

Primary Outcome Measures

Name	Time	Method
Restenosis rate	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	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 Outcome Measures

Name	Time	Method
Rutherford scale	Immediately after procedure	Clinical success is to be defined as an improvement in Rutherford scale of at least one category after the procedure.
ABI value	Immediately after procedure	Hemodynamic success is to be defined as an improvement of ABI value by ≥ 0.1 after the procedure and lack of deterioration \> 0.15 in relation to the maximal value recorded before the procedure.
Residual stenosis	Immediately after procedure	The technical success of the procedure is to be defined as PTA of a lesion with \>30 % residual stenosis and lack of flow rate-limiting dissection immediately after treatment.

Trial Locations

Locations (1)

Shanghai Tenth people's hospital, Tongji university; 🇨🇳 Shanghai, Shanghai, China