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

NCT05246410 | Unknown

• 1 other identifier: Acoart-08
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Spot stent system

EXPERIMENTAL

A system that loaded multi low radial force stents on one catheter.

Device: Spot stent system

Self-Expanding peripheral stent system

ACTIVE COMPARATOR

A conventional stent system that commonly used.

Device: Self-expanding peripheral stent system

Interventions

Spot stent system DEVICE

Spot stent system designed and produced by Acotec

Spot stent system

Self-expanding peripheral stent system DEVICE

Self-expanding peripheral stent system designed and produced by Ev3, Inc

Self-Expanding peripheral stent system

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acotec Scientific Co., Ltd: lead

Study Sites (2)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Zhejiang Provincial People'S Hospital

Zhejiang, Zhejiang, 310014, China

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Guo Wei, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo Wei, MD

CONTACT

010-66887329; pla301dml@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: August 17, 2022
• Primary Completion: November 28, 2024
• Study Completion: December 30, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CN (2)