ACOART BTK RENEW：A Post Market Clinical Study
This trial has no sites in United States.
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT04885985, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Acotec Scientific Co., Ltd
- Trial code
- NCT04885985
- Record updated
- 1 August 2024
- Original description
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.Read full original descriptionShow less
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: 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: 5. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment; 9. History of stroke within 90 days prior to enrollment; 15. Patients who have participated in clinical trials of other medical devices or drugs during the same period; 2. Acute vessel occlusion or acute thrombosis in target lesion; 10. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy; 11. Uncorrectable bleeding diathesis; 1. Plasma creatinine clearance rate <30 mL/min; 3. Planned amputation on the target limb; 4. Subjects confined to bed that are completely non-ambulatory; 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; 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.