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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Device: Ton-bridge carotid stent; Device: WALLSTENT carotid stent

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.

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heng Wang; Phone Number: 18826260512; Email: heng.wang@ton-bridge.com

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital, Capital Medical University
    • Principal Investigator: Bin Yang
  • Liaoning
    • Shenyang, Liaoning, China
      • The People's Hospital of Liaoning Province
      • Principal Investigator: Peizhuo Zang
  • Shandong
    • Linyi, Shandong, China
      • Linyi People's Hospital
      • Principal Investigator: Hongxing Han
    • Qingdao, Shandong, China
      • The Affiliated Hospital Of Qingdao University
      • Principal Investigator: Yong Zhang
    • Qingdao, Shandong, China
      • Qingdao Central Hospital
      • Principal Investigator: Haicheng Yuan
  • Shangdong
    • Jinan, Shangdong, China
      • Central Hospital Affiliated to Shangdong First Medical University
      • Principal Investigator: Liqun Jiao
  • Zhejiang
    • Lishui, Zhejiang, China
      • Lishui Central Hospital
      • Principal Investigator: Xueli Cai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• 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).
• The target lesion vessel has intraluminal filling defect, thrombosis, occlusion or subtotal occlusion ("string sign").
• Severe tortuous anatomy or other anatomic factors that prohibit the safe placement of the catheter or stent systems.
• Pregnant or lactating female.
• Patient is participating in an investigational drug or device study where the primary endpoint has not yet been completed or that will clinically interfere with the endpoint of this investigation.
• Other circumstances which the investigator considers unsuitable for participating in this investigation.

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: experimental group; Carotid artery stenting with the experimental device	Device: Ton-bridge carotid stent; carotid artery stenting with Ton-bridge carotid stent
Active Comparator: control group; Carotid artery stenting with the control device	Device: WALLSTENT carotid stent; carotid artery stenting with WALLSTENT carotid stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Proportion of participants who achieve technical success. Technical success is defined as successful implantation of the carotid stent and successful retraction of the delivery catheter.	Intraprocedure
Procedural success	Proportion of participants who achieve procedural success. Procedural success is defined as stent technical success with <50% residual stenosis and no MAE in-hospital or 7 days post-procedure.	before discharge or up to 7 days
Target lesion revascularization (TLR)	TLR is defined as any invasive revascularization procedure that is performed to reperfuse or increase the luminal diameter of the vessel inside or within 5mm of the previously treated lesion.	Up to 1 year
Ipsilateral stroke between 31 days and 1 year post-procedure	Incidence of any ipsilateral stroke between 31 days and 1 year post-procedure.	Between 31 days and 1 year
In-stent restenosis	Defined as ≥50% diameter stenosis within the stented lesion or within 5mm proximal or distal to the stent.	180±30 days, 360±30 days
mRS score	Modified Rankin Scale score of participants in every evaluation time point.	30±7 days, 180±30 days, 360±30 days
Device deficiency	Defined as the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical investigations, such as labeling errors, quality problems, malfunctions, etc.	Up to 1 year
Incidence of MAE	MAE is defined as any death, stroke or myocardial infarction.	Up to 1 year
Incidence of Adverse events (AE)	Defined as untoward medical event occurring during the course of clinical investigation, whether or not related to the medical device.	Up to 1 year
Incidence of Serious adverse events (SAE)	Defined as the event occurring during the course of clinical investigation, which leads to death or serious deterioration in the health, including a life-threatening illness or injury; a permanent impairment of a body structure or a body function; in-patient or prolonged hospitalization; medical or surgical intervention to prevent permanent impairment to a body structure or a body function; foetal distress, foetal death, congenital abnormality or birth defect, etc.	Up to 1 year

Collaborators and Investigators

• Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Investigators: Principal Investigator: Liqun Jiao, Central Hospital Affiliated to Shangdong First Medical University; Principal Investigator: Yong Zhang, The Affiliated Hospital Of Qingdao University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: ZHTQ202301

Drug and device information, study documents

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