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.

Acotec Scientific Co., Ltd2 sites in 1 country196 target enrollmentAugust 17, 2022

ConditionsPeripheral Vascular Disease (PVD)Peripheral Arterial Disease (PAD)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Vascular Disease (PVD)
Sponsor: Acotec Scientific Co., Ltd
Enrollment: 196
Locations: 2
Primary Endpoint: The primary patency rate of target lesion at 12 months post-procedure
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 17, 2022

End Date

December 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Acotec Scientific Co., Ltd

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

The primary patency rate of target lesion at 12 months post-procedure

Time Frame: 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 Outcomes

Rate of device success(immediate post-procedure)
Rate of procedural success(7 days post-procedure)
Rate of clinically driven target lesion revascularization within 12 months post-procedure(12 months post-procedure)
The change of Rutherford class from baseline(12 months post-procedure)
The change of ankle-brachial index (ABI) from baseline(12 months post-procedure)
Rate of composite safety endpoint(30 days post-procedure)