ACOART BTK RENEW：A Post Market Clinical Study

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

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.

Inclusion Criteria:

• 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 Criteria:

• 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