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.

Acotec Scientific Co., Ltd1 site in 1 country166 target enrollmentDecember 8, 2021

ConditionsPeripheral Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Acotec Scientific Co., Ltd
Enrollment: 166
Locations: 1
Primary Endpoint: The primary patency rate of target lesion at 12 months post-procedure
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 8, 2021

End Date

July 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Acotec Scientific Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The primary patency rate of target lesion at 12 months post-procedure

Time Frame: 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 Outcomes

Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure(12 months post-procedure)
Rate of device success(immediate post-procedure)
The change of ankle-brachial index (ABI) from baseline(12 months post-procedure)
The change of Rutherford class from baseline(12 months post-procedure)
Rate of composite safety endpoint(30 days post-procedure)