Using Sirolimus coated balloons to treat blocked arteries in the leg

A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety Between Sirolimus Coated Balloon Catheter and Paclitaxel Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis.

This study is testing whether Sirolimus coated balloons can work better and be safer than Paclitaxel coated balloons for treating blocked arteries in the legs of patients with certain types of blood flow problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Acotec Scientific Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT04982367 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness and safety of Sirolimus coated balloon catheters against Paclitaxel coated balloon catheters for treating stenosis in the femoropopliteal artery. It is a prospective randomized trial involving patients with lower extremity arterial occlusive diseases classified as Rutherford 2-5. Participants will be evaluated based on their response to the treatment, focusing on the degree of stenosis and the length of the target lesion. The study will assess outcomes related to blood flow improvement and potential complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with severe stenosis or occlusion in the femoropopliteal artery.

Not a fit: Patients with significant renal impairment, multiple lesions, or recent surgical interventions on the target limb may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with peripheral artery disease, potentially improving their quality of life.

How similar studies have performed: Previous studies have shown promising results with drug-eluting balloon catheters, suggesting that this approach may be effective, although the specific comparison of Sirolimus versus Paclitaxel is less explored.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years old and ≤80 years old
* Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
* SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.
* The length of target lesion less than 20 cm
* Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed

Exclusion Criteria:

* The plasma creatinine level is higher than 150 umol/L
* Thrombolysis or thrombectomy is required
* There are more than 2 lesion need to treat in the target vessel.
* The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
* The target lesion had residual stenosis\>30% or flow-limit dissection after pre-dilatation.
* The patient had outflow less than 1 vessel
* The lesion located in a stent.
* Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated.
* Women who are pregnant or breast-feeding.
* The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
* Patient has life expectancy of less than 12 months.
* The investigator think the patient is not suitable for participation in the clinical trial.

Where this trial is running

Beijing, Beijing

• Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Guo Wei, MD — Chinese PLA General Hospital
• Study coordinator: Guo Wei, MD

Conditions Peripheral Artery Disease; Drug eluting balloon catheter