A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.

Acotec Scientific

Status: Enrolling

Conditions: Peripheral Arterial Disease (PAD); Peripheral Vascular Disease (PVD)

Treatments: Device: Spot stent system; Device: Self-expanding peripheral stent system

Study type: Interventional

Funder types: Industry

Identifiers

NCT05246410

Acoart-08

Details and patient eligibility

About

A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.

Full description

The objective of this clinical investigation is to assess the efficacy and safety of spot stent system ,which is indicated for use in patients with atherosclerotic disease of the superficial femoral artery (SFA) or proximal popliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Spot stent system

Experimental group

Description:

A system that loaded multi low radial force stents on one catheter.

Treatment:

Device: Spot stent system

Self-Expanding peripheral stent system

Active Comparator group

Description:

A conventional stent system that commonly used.

Treatment:

Device: Self-expanding peripheral stent system