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

Acotec Scientific

Status: Enrolling

Conditions: Peripheral Artery Disease

Treatments: Device: Sirolimus-eluting balloon catheter; Device: Paclitaxel-eluting balloon catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT04982367

Acoart SCB SFA

Details and patient eligibility

About

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

Enrollment: 166 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Sirolimus-eluting balloon angioplasty

Experimental group

Description:

Using Sirolimus Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

Treatment:

Device: Sirolimus-eluting balloon catheter

Paclitaxel-eluting balloon angioplasty

Active Comparator group

Description:

Using Paclitaxel Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

Treatment:

Device: Paclitaxel-eluting balloon catheter