Evaluating a new stent system for treating blocked leg arteries

A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Spot Stent System Using in the Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries.

This study tests a new type of stent for people with blocked leg arteries to see if it works better and is safer than a standard stent.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Acotec Scientific Co., Ltd (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT05246410 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to compare the efficacy and safety of a new spot stent system against a self-expanding peripheral stent system for patients with stenotic disease in the femoropopliteal arteries. The trial is prospective and randomized, focusing on individuals with atherosclerotic disease affecting the superficial femoral artery or proximal popliteal arteries. Participants will undergo treatment to assess improvements in blood flow and overall safety outcomes following the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with significant stenosis or occlusion in the superficial femoral artery or proximal popliteal artery.

Not a fit: Patients with elevated plasma creatinine levels or those who have undergone recent thrombolysis or thrombectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from peripheral vascular disease.

How similar studies have performed: Other studies have shown promising results with similar stent systems, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years old and ≤80 years old
* Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
* Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee), located ≥1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal artery at the superior end of the patella.
* Target lesion had severe stenosis (stenosis degree ≥70%) or occlusion.
* Presence of at least one patent infrapopliteal vessel.
* The length of target lesion ≥10 cm.
* After predilation, the target lesion has \<30% residual stenosis and presence of at least one flow-limiting dissection (by visual estimate).
* 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.
* The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
* Previously implanted stent in the target lesion.
* The guide wire can not cross the target lesion.
* Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable.
* Patient has a known allergy to anticoagulant drugs, anti-platelet drugs 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.
* Patient who planned to do above the ankle amputation before the operation.
* Patient who had severe hemorrhage or coagulation disorder which judged by the investigator.
* The investigator think the patient is not suitable for participation in the clinical trial.

Where this trial is running

Beijing, Beijing and 1 other locations

• Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
• Zhejiang Provincial People'S Hospital — Zhejiang, Zhejiang, China (Recruiting)

Study contacts

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

Conditions Peripheral Vascular Disease; Peripheral Arterial Disease