RecruitingNot ApplicableNCT04885985
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
Sponsor
Acotec Scientific Co., Ltd
Enrollment
107 participants
Start Date
Dec 31, 2021
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- \. Age ≥18 years old and ≤75 years old
- \. Rutherford clinical category classification：3,4 or 5
- \. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
- \. Reference vessel diameter is between 2 mm and 4 mm
- \. 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 Criteria15
- \. Plasma creatinine clearance rate <30 mL/min
- \. Acute vessel occlusion or acute thrombosis in target lesion
- \. Planned amputation on the target limb
- \. Subjects confined to bed that are completely non-ambulatory.
- \. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
- \. Life expectancy < 5 year.
- \. Cumulative length of 100% occluded target lesion(s)>150 mm
- \. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm
- \. History of stroke within 90 days prior to enrollment
- \. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
- \. Uncorrectable bleeding diathesis
- \. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery
- \. Pregnant or breastfeeding female subjects
- \. Ability to cross a guidewire through target lesion
- \. Patients who have participated in clinical trials of other medical devices or drugs during the same period
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Interventions
DEVICEDEB catheter
Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04885985
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