ACOART BTK RENEW：A Post Market Clinical Study

Recruiting now · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

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.

Key facts

Study ID: NCT04885985
Run by: Acotec Scientific Co., Ltd
People needed: 107
Starts: 2021-12-31
Expected to finish: 2027-04-01
Last updated by the study team: 2024-08-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Chui Yang Liu Hospital affiliated to Tsinghua University — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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