Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis

NCT06365697 | Active Not Recruiting

• 1 other identifier: ZHTQ202301
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis.

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Incidence of non-MAE(major adverse events) within 30 days post-procedure

  MAE is defined as any death, stroke or myocardial infarction.

  Up to 30 days

Secondary Outcomes (10)

• Technical success

  Intraprocedure

• Procedural success

  before discharge or up to 7 days

• Target lesion revascularization (TLR) rate

  Up to 1 year

• Ipsilateral stroke between 31 days and 1 year post-procedure

  Between 31 days and 1 year

• In-stent restenosis rate

  180±30 days, 360±30 days

Study Arms (2)

experimental group

EXPERIMENTAL

Carotid artery stenting with the experimental device

Device: Ton-bridge carotid stent

control group

ACTIVE COMPARATOR

Carotid artery stenting with the control device

Device: WALLSTENT carotid stent

Interventions

Ton-bridge carotid stent DEVICE

carotid artery stenting with Ton-bridge carotid stent

experimental group

WALLSTENT carotid stent DEVICE

carotid artery stenting with WALLSTENT carotid stent

control group

Eligibility Criteria

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

You may qualify if:

• Patient is 18-80 years old and of any sex;
• Patient is diagnosed with carotid atherosclerotic stenosis by imaging. The lesion site is located in the extracranial segment of carotid artery and is suitable for endovascular treatment. Patient is either symptomatic with carotid stenosis≥50% or asymptomatic with carotid stenosis≥70% as determined by digital subtraction angiography (DSA) using NASCET methodology.
• Symptomatic is defined as non-disabling ischemic stroke (mRS≤2) or transient cerebral ischemia (TIA, including cerebral hemispheric neurological events and amaurosis fugax) associated with the carotid stenosis within the past 6 months.
• The target vessel reference diameter ranges from 3.5mm to 9mm.
• Patient has been informed of the nature of this trial, understood the purpose of this clinical investigation, and volunteered to participate and sign the informed consent form.

You may not qualify if:

• Evolving stroke within 3 months before index procedure, disabling stroke (mRS≥3) before the procedure, or massive cerebral infarction (area of infarction is \>1/3 of the ipsilateral middle cerebral artery territory) within 30 days before the procedure.
• Myocardial infarction within 30 days prior to index procedure.
• Severe heart, lung, liver, or renal insufficiency.
• Patient has known bleeding diathesis, or contraindication to heparin or antiplatelet therapy.
• Patient has a known allergy to contrast media or nickel-titanium material.
• Disturbance of consciousness, dementia, or severe neurological deficits (NIHSS≥15 or mRS≥3)
• Severe hypertension (Systolic blood pressure≥180mmHg and/or diastolic blood pressure≥110mmHg) difficult to be controlled.
• Patient has known risk factors for embolization.
• Patient has had any major surgical procedure (i.e., intraabdominal or intrathoracic surgery, any surgery or interventional procedure involving cardiac, cerebral or vascular system) within 30 days before index procedure.
• Patient has had any intracranial surgery or intracranial hemorrhage within 1 year before index procedure.
• Patient has other known neurological diseases such as intracranial tumor, which may confound the neurological assessments.
• Intracranial aneurysm or arteriovenous malformation, which requires treatment.
• Patient has other known vascular lesion requiring intervention at the same time or within 30 days after index procedure.
• Patient has other carotid diseases such as vasculitis, carotid dissection, carotid aneurysm and fibromuscular dysplasia.
• Ipsilateral intracranial artery severe stenosis (≥70%), occlusion or dissection; stenosis(≥50%) or occlusion of ipsilateral common carotid artery opening or brachiocephalic artery; any previously placed stent in the ipsilateral carotid artery or brachiocephalic artery; the target lesion is a restenosis after a previous carotid endarterectomy (CEA).

Sponsors & Collaborators

• Ton-Bridge Medical Tech. Co., Ltd: lead

Study Sites (7)

The People's Hospital of Liaoning Province

Shenyang, Liaoning, China

Location

Linyi People's Hospital

Linyi, Shandong, China

Location

Qingdao Central Hospital

Qingdao, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Central Hospital Affiliated to Shangdong First Medical University

Jinan, Shangdong, China

Location

Lishui Central Hospital

Lishui, Zhejiang, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Liqun Jiao

  Central Hospital Affiliated to Shangdong First Medical University

  PRINCIPAL INVESTIGATOR

• Yong Zhang

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

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: April 9, 2024
• First Posted: April 15, 2024
• Study Start: April 24, 2024
• Primary Completion: December 11, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (7)