A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 1\. Age ≥18 years old and ≤75 years old
• 2\. Rutherford clinical category classification：3,4 or 5
• 3\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
• 4\. Reference vessel diameter is between 2 mm and 4 mm
• 5\. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
Locations
Other Locations
China
Chui Yang Liu Hospital affiliated to Tsinghua University
RECRUITING
Beijing
Contact Information
Primary
Zhuang Baixi
zhuangbaixi@163.com
010-62835122
Time Frame
Start Date: 2021-12-31
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 107
Treatments
Experimental: DEB catheter
Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm
Related Therapeutic Areas
Sponsors
Leads: Acotec Scientific Co., Ltd