Status:
RECRUITING
ACOART BTK RENEW：A Post Market Clinical Study
Lead Sponsor:
Acotec Scientific Co., Ltd
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 l...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. Plasma creatinine clearance rate \<30 mL/min
- 2\. Acute vessel occlusion or acute thrombosis in target lesion
- 3\. Planned amputation on the target limb
- 4\. Subjects confined to bed that are completely non-ambulatory.
- 5\. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
- 6\. Life expectancy \< 5 year.
- 7\. Cumulative length of 100% occluded target lesion(s)\>150 mm
- 8\. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm
- 9\. History of stroke within 90 days prior to enrollment
- 10\. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
- 11\. Uncorrectable bleeding diathesis
- 12\. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery
- 13\. Pregnant or breastfeeding female subjects
- 14\. Ability to cross a guidewire through target lesion
- 15\. Patients who have participated in clinical trials of other medical devices or drugs during the same period
Key Trial Info
Start Date :
December 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04885985
Start Date
December 31 2021
End Date
April 1 2027
Last Update
August 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chui Yang Liu Hospital affiliated to Tsinghua University
Beijing, Beijing Municipality, China, 100021