DEB catheter: Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Primary Patency — 6 month Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.
Trial sites (1)
Facility
City
Region
Status
Chui Yang Liu Hospital affiliated to Tsinghua University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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