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

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.

Official Title
-----------------
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.

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Drug eluting balloon angioplasty
* Device: Conventional balloon angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Peripheral vascular disease with or without diabetes. Rutherford class 2-6. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug eluting balloon angioplasty<br>Paclitaxel coated balloon angioplasty | Device: Drug eluting balloon angioplasty<br>* 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.<br>|
| Active Comparator: Conventional balloon angioplasty<br>Conventional balloon angioplasty | Device: Conventional balloon angioplasty<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate | 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). | 12 months | 
| Peak systolic velocity ratio | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rutherford scale | Clinical success is to be defined as an improvement in Rutherford scale of at least one category after the procedure. | Immediately after procedure | 
| ABI value | 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. | Immediately after procedure | 
| Residual stenosis | 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. | Immediately after procedure |