💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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