Efficacy and Safety of the Ton-bridge Carotid Stent for the Treatment of Carotid Artery Stenosis: a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial

Ton-Bridge Medical Tech. Co., Ltd7 sites in 1 country188 target enrollmentApril 24, 2024

ConditionsCarotid Artery Stenosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Carotid Artery Stenosis
Sponsor: Ton-Bridge Medical Tech. Co., Ltd
Enrollment: 188
Locations: 7
Primary Endpoint: Incidence of non-MAE(major adverse events) within 30 days post-procedure
Status: Active, Not Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

This is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial carried out in 7 research centers in China. Patients with carotid atherosclerotic stenosis will be randomized (1:1) to either the Ton-bridge carotid stent or WALLSTENT carotid stent for treatment. The purpose of this clinical trial is to evaluate the effectiveness and safety of a novel carotid stent, the Ton-bridge carotid stent, in humans for treatment.

Registry

clinicaltrials.gov

Start Date

April 24, 2024

End Date

October 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ton-Bridge Medical Tech. Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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

Time Frame: Up to 30 days

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

Secondary Outcomes

Target lesion revascularization (TLR) rate(Up to 1 year)
Incidence of Serious adverse events (SAE)(Up to 1 year)
Technical success(Intraprocedure)
Procedural success(before discharge or up to 7 days)
Device deficiency(Up to 1 year)
Incidence of MAE(Up to 1 year)
Incidence of Adverse events (AE)(Up to 1 year)
mRS score(30±7 days, 180±30 days, 360±30 days)
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)