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

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.

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

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Sirolimus-eluting balloon catheter; Device: Paclitaxel-eluting balloon catheter

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guo Wei, MD; Phone Number: 010-66887329; Email: pla301dml@vip.sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Wei Guo, MD; Phone Number: 010-66887329; Email: pla301dml@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sirolimus-eluting balloon angioplasty; 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; Sirolimus-eluting balloon catheter designed and produced by Acotec; Other Names: Sirolimus coated balloon catheter
Active Comparator: Paclitaxel-eluting balloon angioplasty; 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; Paclitaxel-eluting balloon catheter (trade name:DHALIA); Other Names: Paclitaxel coated balloon catheter

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Investigators: Principal Investigator: Guo Wei, MD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; Drug eluting balloon catheter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Anti-Bacterial Agents; Protein Kinase Inhibitors; Antibiotics, Antineoplastic; Antifungal Agents; Paclitaxel; Albumin-Bound Paclitaxel; Sirolimus; Temsirolimus; MTOR Inhibitors
• Other Study ID Numbers: Acoart SCB SFA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No