A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of Sperstent® Peripheral Spot Stent System Used for the Residual Lesions After Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries

FrontAce Scientific Co., Ltd12 sites in 1 country240 target enrollmentJune 4, 2024

ConditionsPeripheral Arterial Disease Stenosis Dissection

Overview

Phase: N/A
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: FrontAce Scientific Co., Ltd
Enrollment: 240
Locations: 12
Primary Endpoint: Freedom from Major Adverse Events (MAEs)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-PTA) residual lesions including stenoses and/or dissections in femoral and proximal popliteal arteries.

Registry

clinicaltrials.gov

Start Date

June 4, 2024

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

FrontAce Scientific Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-85 years old, male or female;
•The target lesion is located in the superficial femoral artery or the proximal popliteal artery;
•Peripheral arterial stenosis or occlusive disease with symptoms consistent with the Rutherford classification 2 to 5;
•Estimated life expectancy \>1 year;
•Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.
•Angiographic Inclusion Criteria:
•Stenosis rate ≥70% under DSA by visual estimate, or 100% occluded lesion with a total lesion length less than 150mm (by visual estimate);
•Reference vessel diameter is between 3 mm and 7.5 mm, 50mm≤Total cumulative length of target lesions≤250mm; (In the case of bilimb lesions, a single target lesion with one limb meeting the protocol criteria is selected by the investigator; More than 2cm between lesions are considered as 2 lesions);
•After PTA treatment by DCB, there exists residual lesions, such as the target lesion has over 30% residual DS and/or presence of at least one post-PTA dissection (Type A-F) (by visual estimate);
•Patients with unobstructed inflow tract or successfully treated, visual residual stenosis ≤50%;

Exclusion Criteria

•Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis;
•Patients with serum creatinine \>2.5mg/dl during screening or undergoing long-term hemodialysis or peritoneal dialysis;
•Severe coagulation disorder;
•Patients with major vascular-related diseases, including acute lower extremity ischemia, active disseminated intravascular coagulation, thromboangiitis obliterans, deep vein thrombosis, and aneurysms of therapeutic lateral vessels (deep femur, superficial femur, or popliteal artery);
•A history of major organ failure or other serious illness (including severe coronary heart disease, severe cardiac insufficiency, severe neurosis, or mental illness); Have received or plan organ transplantation, severe gastrointestinal bleeding);
•Myocardial infarction or symptomatic stroke occurred within 3 months prior to enrollment;
•Thrombolysis of target vessel within 72 hours before surgery, did not completely dissolve the thrombus;
•Systemic infection or uncontrolled infection within the target limb;
•Known allergy to contrast agents, nickel or titanium (Nitinol), heparin, aspirin, clopidogrel, anesthetics;
•Women who are pregnant or breast-feeding, or women of childbearing age who have family plans within 1 year;

Outcomes

Primary Outcomes

Freedom from Major Adverse Events (MAEs)

Time Frame: 30 days post-operation

Freedom from the occurrence of any new-onset MAEs defined as all-cause death, index limb amputation (above the ankle), or clinically-driven target lesion revascularization (CD-TLR) at 30 days post-operation.

Primary Patency

Time Frame: 12 months post-operation

Primary patency defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 12 months post-operation.(defined as PSVR \>2.5)

Secondary Outcomes

Duplex Ultrasound (DUS) Derived Lesion Patency(30 days, 6 months and 12 months post-operation)
Rate of clinically driven target lesion revascularization (CD-TLR)(30 days, 6 months and 12 months post-operation)
Rate of major adverse event(s) (MAEs)(6 months and 12 months post-operation)
Rate of Device Success(immediately post-operation)
Rate of Procedural Success(immediately post-operation)
Primary Patency at 30 days and 6 months(30 days and 6 months post-operation)
Changes from Baseline in Rutherford Classification(30 days, 6 months and 12 months post-operation)
Changes from Baseline in Ankle-brachial Index (ABI)(30 days, 6 months and 12 months post-operation)
Rate of Stent Fracture(12 months post-operation)