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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease (PAD); Peripheral Vascular Disease (PVD)
• Intervention / Treatment: Device: Spot stent system; Device: Self-expanding peripheral stent system

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 Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guo Wei, MD; Phone Number: 010-66887329; Email: pla301dml@vip.sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Wei Guo, MD; Phone Number: 010-66887329; Email: pla301dml@vip.sina.com
  • Zhejiang
    • Zhejiang, Zhejiang, China, 310014
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Jinsong Jiang; Email: jiangjinsong082022@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spot stent system; A system that loaded multi low radial force stents on one catheter.	Device: Spot stent system; Spot stent system designed and produced by Acotec
Active Comparator: Self-Expanding peripheral stent system; A conventional stent system that commonly used.	Device: Self-expanding peripheral stent system; Self-expanding peripheral stent system designed and produced by Ev3, Inc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Rutherford class from baseline	Defined as change in target limb Rutherford class from baseline to 12 months	12 months post-procedure
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
Rate of device success	Defined as successful delivery, release and retrieval of the device.	immediate post-procedure
Rate of procedural success	Defined as no provisional stent implanted or major adverse event occured prior to discharge.	7 days post-procedure
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
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

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Investigators: Principal Investigator: Guo Wei, MD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Estimated): November 28, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: Acoart-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No