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Carotid Artery StenosisNCT06365697

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

A study testing Ton-bridge carotid stent and WALLSTENT carotid stent in people with Carotid Artery Stenosis, run by Ton-Bridge Medical Tech. Co., Ltd at 7 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Carotid Artery Stenosis
What is being tested?
Ton-bridge carotid stent and WALLSTENT carotid stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
7 sitesChina
Study dates
24 Apr 2024to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 20Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Xuanwu Hospital, Capital Medical University

    Beijing

  • Central Hospital Affiliated to Shangdong First Medical University

    Jinan, Shangdong

  • Linyi People's Hospital

    Linyi, Shandong

  • Lishui Central Hospital

    Lishui, Zhejiang

  • Qingdao Central Hospital

    Qingdao, Shandong

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Ton-bridge carotid stent, WALLSTENT carotid stent
Medical subject headings
Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ton-bridge carotid stentDevice

    carotid artery stenting with Ton-bridge carotid stent

  • WALLSTENT carotid stentDevice

    carotid artery stenting with WALLSTENT carotid stent

Study groups in NCT06365697
Study groupRoleWhat they receive
experimental groupExperimentalCarotid artery stenting with the experimental device
Receives: Device: Ton-bridge carotid stent
control groupActive comparatorCarotid artery stenting with the control device
Receives: Device: WALLSTENT carotid stent

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to 30 days

Secondary outcomes (10)

  1. 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.

    Measured: Intraprocedure

  2. 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.

    Measured: before discharge or up to 7 days

  3. Target lesion revascularization (TLR) rate

    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.

    Measured: Up to 1 year

  4. Ipsilateral stroke between 31 days and 1 year post-procedure

    Incidence of any ipsilateral stroke between 31 days and 1 year post-procedure.

    Measured: Between 31 days and 1 year

  5. In-stent restenosis rate

    In-stent restenosis is defined as ≥50% diameter stenosis within the stented lesion or within 5mm proximal or distal to the stent.

    Measured: 180±30 days, 360±30 days

  6. mRS score

    Modified Rankin Scale (mRS) score of participants in every evaluation time point. The mRS score is generally to assess disability in patients who have suffered a stroke and ranges from 0 to 6. Higher scores mean a more severe disability. 6 means death.

    Measured: 30±7 days, 180±30 days, 360±30 days

  7. 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.

    Measured: Up to 1 year

  8. Incidence of MAE

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

    Measured: Up to 1 year

  9. 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.

    Measured: Up to 1 year

  10. 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.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2024
  2. Study start24 Apr 2024
  3. Primary completion11 Dec 2024
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06365697
Sponsor's protocol ID
ZHTQ202301
Status last verified
Dec 2025
First submitted
9 Apr 2024
Last updated
2 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ton-bridge carotid stent and WALLSTENT carotid stent in people with Carotid Artery Stenosis, run by Ton-Bridge Medical Tech. Co., Ltd at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of non-MAE(major adverse events) within 30 days post-procedure (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06365697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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