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

Not Applicable

Recruiting

• Conditions: Peripheral Artery Disease
• Interventions: Device: Paclitaxel-eluting balloon catheter; Device: Sirolimus-eluting balloon catheter

• Registration Number: NCT04982367
• Lead Sponsor: Acotec Scientific Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-29
• Study Start: 2021-12-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 166

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel-eluting balloon angioplasty	Paclitaxel-eluting balloon catheter	Using Paclitaxel Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Sirolimus-eluting balloon angioplasty	Sirolimus-eluting balloon catheter	Using Sirolimus Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

Primary Outcome Measures

Name	Time	Method
The primary patency rate of target lesion at 12 months post-procedure	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)

Secondary Outcome Measures

Name	Time	Method
Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure	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
Rate of device success	immediate post-procedure	Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
The change of ankle-brachial index (ABI) from baseline	12 months post-procedure	Defined as change of target limb ABI from baseline to 12 months
The change of Rutherford class from baseline	12 months post-procedure	Defined as change in target limb Rutherford class from baseline to 12 months
Rate of composite safety endpoint	30 days post-procedure	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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China