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.
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Guo Wei, MD
pla301dml@vip.sina.com
010-66887329
Time Frame
Start Date: 2021-12-08
Estimated Completion Date: 2024-07
Participants
Target number of participants: 166
Treatments
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
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
Related Therapeutic Areas
Sponsors
Leads: Acotec Scientific Co., Ltd