Evaluating a new drug-coated balloon for treating below-the-knee artery lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to gather data on the safety and effectiveness of the Acotec Litos&Tulip Drug-coated Balloon catheters for patients with peripheral artery disease. It is a prospective, multi-center, single-arm study focusing on patients with significant stenosis or occlusions in below-the-knee arteries. Participants will receive treatment with the drug-coated balloon catheter and will be monitored for outcomes related to their condition. The study seeks to provide further insights into the performance of this intervention in a real-world setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Chui Yang Liu Hospital affiliated to Tsinghua University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Zhuang Baixi — Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Study coordinator: Zhuang Baixi
• Email: zhuangbaixi@163.com
• Phone: 010-62835122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.