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

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

This study is testing a new drug-coated balloon treatment for people with peripheral artery disease to see if it helps improve blood flow in their lower legs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 107 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Acotec Scientific Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04885985 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with significant below-the-knee artery lesions and a Rutherford classification of 3, 4, or 5.

Not a fit: Patients with severe renal impairment, acute vessel occlusion, or those who are non-ambulatory may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options for patients suffering from peripheral artery disease.

How similar studies have performed: Other studies have shown promise with drug-coated balloons in treating peripheral artery disease, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions Peripheral Artery Disease