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

Peripheral Artery Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982367
• Other study ID #: Acoart SCB SFA
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Acotec Scientific Co., Ltd
• Contact: Guo Wei, MD
• Phone: 010-66887329
• Email: pla301dml[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Sirolimus-eluting balloon catheter
Sirolimus-eluting balloon catheter designed and produced by Acotec
• Paclitaxel-eluting balloon catheter
Paclitaxel-eluting balloon catheter (trade name:DHALIA)

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	The change of Rutherford class from baseline	Defined as change in target limb Rutherford class from baseline to 12 months	12 months post-procedure
Secondary	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
Secondary	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