Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis

Study Overview
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Brief Summary
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A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis

Official Title
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A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety Between Sirolimus Coated Balloon Catheter and Paclitaxel Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis.

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Sirolimus-eluting balloon catheter
* Device: Paclitaxel-eluting balloon catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old and ≤80 years old Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5 SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion. The length of target lesion less than 20 cm Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed Exclusion Criteria: The plasma creatinine level is higher than 150 umol/L Thrombolysis or thrombectomy is required There are more than 2 lesion need to treat in the target vessel. The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks. The target lesion had residual stenosis>30% or flow-limit dissection after pre-dilatation. The patient had outflow less than 1 vessel The lesion located in a stent. Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated. Women who are pregnant or breast-feeding. The subjects have participated in other drug property studies or device studies that have not yet completed the main end point. Patient has life expectancy of less than 12 months. The investigator think the patient is not suitable for participation in the clinical trial.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sirolimus-eluting balloon angioplasty<br>Using Sirolimus Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery | Device: Sirolimus-eluting balloon catheter<br>* Sirolimus-eluting balloon catheter designed and produced by Acotec<br>* Other names: Sirolimus coated balloon catheter;|
| Active Comparator: Paclitaxel-eluting balloon angioplasty<br>Using Paclitaxel Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery | Device: Paclitaxel-eluting balloon catheter<br>* Paclitaxel-eluting balloon catheter (trade name:DHALIA)<br>* Other names: Paclitaxel coated balloon catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary patency rate of target lesion at 12 months post-procedure | Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4) | 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of device success | Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP) | immediate post-procedure | 
| Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure | Defined as any reintervention at the target lesion due to symptoms or the following index: drop of ABI >20% or ABI >0.15 compared to the post-procedure ABI during 12 months post-procedure | 12 months post-procedure | 
| The change of Rutherford class from baseline | Defined as change in target limb Rutherford class from baseline to 12 months | 12 months post-procedure | 
| The change of ankle-brachial index (ABI) from baseline | Defined as change of target limb ABI from baseline to 12 months | 12 months post-procedure | 
| Rate of composite safety endpoint | Defined a composite rate of device-related or procedure-related death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) or target lesion thrombotic events through 30 days post- procedure | 30 days post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug eluting balloon catheter, Peripheral Artery Disease