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

Not Applicable

Recruiting

• Conditions: Peripheral Vascular Disease (PVD); Peripheral Arterial Disease (PAD)
• Interventions: Device: Spot stent system; Device: Self-expanding peripheral stent system

• Registration Number: NCT05246410
• Lead Sponsor: Acotec Scientific Co., Ltd

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-18
• Study Start: 2022-08-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-11-28
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 196

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spot stent system	Spot stent system	A system that loaded multi low radial force stents on one catheter.
Self-Expanding peripheral stent system	Self-expanding peripheral stent system	A conventional stent system that commonly used.

Primary Outcome Measures

Name	Time	Method
The primary patency rate of target lesion at 12 months post-procedure	12 months post-procedure	Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)

Secondary Outcome Measures

Name	Time	Method
Rate of procedural success	7 days post-procedure	Defined as no provisional stent implanted or major adverse event occured prior to discharge.
Rate of device success	immediate post-procedure	Defined as successful delivery, release and retrieval of the device.
Rate of clinically driven target lesion revascularization within 12 months post-procedure	12 months post-procedure	Defined as any reintervention at the target lesion due to the following symptoms: drop of ABI \>20% or ABI \>0.15 compared to the post-procedure ABI
The change of Rutherford class from baseline	12 months post-procedure	Defined as change in target limb Rutherford class from baseline to 12 months
The change of ankle-brachial index (ABI) from baseline	12 months post-procedure	Defined as change of target limb ABI from baseline to 12 months
Rate of composite safety endpoint	30 days post-procedure	Defined a composite rate of all cause death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) through 30 days post- procedure

Trial Locations

Locations (2)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Zhejiang Provincial People'S Hospital; 🇨🇳 Zhejiang, Zhejiang, China