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

Peripheral Artery Disease

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