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

Peripheral Arterial Disease (PAD) Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246410
• Other study ID #: Acoart-08
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Acotec Scientific Co., Ltd
• Contact: Guo Wei, MD
• Phone: 010-66887329
• Email: pla301dml[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 30, 2024
• Est. primary completion date: November 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Disease (PVD)
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Spot stent system
Spot stent system designed and produced by Acotec
• Self-expanding peripheral stent system
Self-expanding peripheral stent system designed and produced by Ev3, Inc

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Zhejiang Provincial People'S Hospital	Zhejiang	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary patency rate of target lesion at 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)	12 months post-procedure
Secondary	Rate of device success	Defined as successful delivery, release and retrieval of the device.	immediate post-procedure
Secondary	Rate of procedural success	Defined as no provisional stent implanted or major adverse event occured prior to discharge.	7 days post-procedure
Secondary	Rate of clinically driven target lesion revascularization within 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	12 months post-procedure
Secondary	The change of Rutherford class from baseline	Defined as change in target limb Rutherford class from baseline to 12 months	12 months post-procedure
Secondary	The change of ankle-brachial index (ABI) from baseline	Defined as change of target limb ABI from baseline to 12 months	12 months post-procedure
Secondary	Rate of composite safety endpoint	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	30 days post-procedure