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Intracranial AtherosclerosisNCT05593224

The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Intracranial Atherosclerotic Stenosis

A study testing Intracranial Stent (Tonbridge) in people with Intracranial Atherosclerosis, run by Ton-Bridge Medical Tech. Co., Ltd at 14 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of intracranial atherosclerotic stenosis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Intracranial Atherosclerosis
What is being tested?
Intracranial Stent (Tonbridge)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
14 sitesChina
Study dates
Nov 2022to May 2025
Phase
Interventional
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75
  • Subjects with symptomatic intracranial atherosclerotic stenosis who do not respond to antiplatelet therapy or have poor compensation of collateral circulation and hypoperfusion in the offending vessel blood supply
  • The last onset time of TIA is not limited or the last onset of ischemic stroke is more than 2 weeks
  • The lesion is confirmed to be located in intracranial large arteries, including intracranial segment of the internal carotid artery, middle cerebral artery, intracranial segment of vertebral artery and the basilar artery
  • Target vessel diameter≥2.0mm and ≤4.5mm, lesion length ≤33mm
  • Stenosis degree of intracranial arteries≥70% and ≤99% measured by intracranial angiography (WASID method)
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  • Intracranial artery stenosis which requiring interventional treatment is a single lesion
  • Subjects have at least 1 atherosclerotic plaque risk factor including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, and smoking history
  • mRS≤2 before enrollment
  • Voluntarily participate in this study and sign the informed consent form, can complete examinations and follow-ups in accordance with the requirements of the protocol during the clinical trial

Who cannot join

  • Intracranial arterial stenosis caused by non-atherosclerotic lesions: such as arterial dissection, moyamoya disease, vasculitis, active arteritis, etc.
  • Preoperative MRI shows only perforator infarction in the target lesion
  • Preoperative CT or MRI indicates the presence of post-infarct hemorrhagic transformation in the target vascular, or a history of subarachnoid, subdural, and epidural hemorrhage within 30 days before procedure, or the presence of untreated chronic subdural hematoma (≥5mm)
  • Severe calcification of target vessels; or target vessel tortuosity or other reasons will make experimental device difficult to reach the target lesion position
  • There is more than 70% stenosis in the distal intracranial large vessels or proximal intracranial and extracranial large vessels of the target vessels, and the presence of unidentified responsible lesions
  • Subjects have a major surgery within 30 days before procedure or intend to be hospitalized for other procedure within 6 months after procedure
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  • Intracranial tumors or intracranial arteriovenous malformations, or distal and proximal target vessels combined with aneurysms
  • The target lesion has a history of stent implantation
  • It is suspected that there is severe allergy or contraindication to aspirin, clopidogrel, heparin, contrast media, nitinol and other drugs and devices related to endovascular therapy
  • There is an underlying source of cardiac thrombus, such as atrial fibrillation, left ventricular thrombus, myocardial infarction within 30 days
  • Subjects with an INR > 1.5 or the presence of nonmodifiable bleeding factors
  • Medically uncontrolled severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg)
  • Severe comorbid conditions or unstable conditions, such as severe heart failure, pulmonary failure, or renal failure (serum creatinine >3.0 mg/dL (264μmol/L)), severe liver insufficiency (ALT or AST >3 times normal), and malignancy
  • Life expectancy is less than two years
  • Women who are pregnant or breastfeeding
  • Subjects unable to complete follow-up due to cognitive impairment, mood disorder, or mental illness
  • Subjects who are enrolled in other clinical trials of drugs/devices and have not yet met the primary endpoint
  • Other circumstances which investigators do not consider are appropriate for intracranial stent treatment

Trial locations and contacts

14 sites in 1 country.

Long Chen contact

13868091267

long.chen@ton-bridge.com

Yuhan Yan contact

15843291055

yh.yan@ton-bridge.com

14 sites in 1 country

China14 sites

  • Baotou City Central Hospital

    Baotou, Neimenggu

    Changchun Jiang

  • The First Hospital of Jilin University

    Changchun, Jilin

    Shouchun Wang

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    Feng Wang

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang

    Congguo Yin

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong

    Yongnan Hao

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Chun Chen

  • The First Affiliated Hospital of Henan Science ＆ Technology University

    Luoyang, Henan

    Jisheng Qi

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

    Wenfeng Cao

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

    Yun Xu

  • Ningbo First Hospital

    Ningbo, Zhejiang

    Zhiqing Lin

  • Changhai Hospital of Shanghai

    Shanghai

    Jianmin Liu

  • Tongji Hospitai of Tongji University

    Shanghai

    Chun Fang

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Conghui Li

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

Other trials in China

About this study

Official title: The Efficacy and Safety of the Intracranial Stent (Tonbridge) in Endovascular Treatment of Intracranial Atherosclerotic Stenosis: A Prospective, Multicenter, Single-Arm Trial

The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of intracranial atherosclerotic stenosis.

Read the detailed description

This is a prospective, multicenter, single-arm clinical trial carried out in 14 centers throughout China. 156 subjects with intracranial atherosclerotic stenosis will be treated with the Intracranial Stent (Tonbridge) for the expansion of vascular stenosis site. The primary objective of this study is to evaluate the effectiveness and safety of the intracranial stent for endovascular treatment of intracranial atherosclerotic stenosis.

Being tested
Intracranial Stent (Tonbridge)
Medical subject headings
Intracranial Arteriosclerosis

What participants receive

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

  • Intracranial Stent (Tonbridge)Device

    The intracranial stent consists of a self-expanding, laser-carved nickel-titanium stent and its delivery system.

Study groups in NCT05593224
Study groupRoleWhat they receive
Intracranial Stent (Tonbridge)ExperimentalPlacement of Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd. ).
Receives: Device: Intracranial Stent (Tonbridge)

What is being measured

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

  1. Incidence of in-stent restenosis at 6 months

    The in-stent restenosis is defined as more than 50% stenosis within stent or distal/proximal ends (within 5 mm), and more than 20% absolute lumen loss. The degree of intracranial artery stenosis are measured qualitatively in DSA examination. WASID study will be used to measure the degree of intracranial artery stenosis.

    Measured: 6 months post-procedure

Secondary outcomes (12)

  1. Device success rate and procedural success rate

    Device success refers to the successful delivery of the stent to the lesion site through the delivery system during procedure, and it is released smoothly and fits well with the vessel wall without bending and displacement; procedural success is defined as stenosis degree less than 30% immediately after procedure.

    Measured: Intraoperation

  2. Incidence of symptomatic in-stent restenosis at 6 months, 1 year, and 2 years

    Symptomatic in-stent restenosis is defined as ischemic stroke or TIA or other ischemic neurological symptoms which are caused by in-stent restenosis.

    Measured: 6 months, 1 year, and 2 years post-procedure

  3. Ratio of mRS 0-2 at 30 days, 6 months, 1 year, and 2 years

    Subjects will be evaluated at the follow-up visits according to the mRS. The mRS 0-2 indicates a good prognosis.

    Measured: 30 days, 6 months, 1 year, and 2 years post-procedure

  4. Incidence of stent restenosis at 1 and 2 years

    Restenosis is defined as more than 50% stenosis within stent or distal/proximal ends (within 5 mm), and more than 20% absolute lumen loss.

    Measured: 1 and 2 years post-procedure

  5. Incidence of any stroke and death within 30 days

    Stroke includes both ischemic and hemorrhagic strokes. Deaths from any cause are included in this data.

    Measured: Within 30 days post-procedure

  6. Mortality at 31 days to 6 months, 6 to 12 months, and 12 to 24 months

    Measured: 31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure

  7. Incidence of ischemic stroke in the target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months

    Measured: 31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure

  8. Incidence of ischemic stroke in non-target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months

    Measured: 31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure

  9. The incidence of any hemorrhagic stroke at 31 days to 6 months, 6 to 12 months, and 12 to 24 months

    Measured: 31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure

  10. Incidence of device deficiency

    Device deficiency is the unreasonable risk that may endanger human health or life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems, malfunctions, etc. Possible device deficiency: labeling errors, product quality problems, design defects, broken sterilization packaging, etc.

    Measured: After use of device to end of study

  11. Incidence of adverse events (AE) at 30 days, 6 months, 1 year, and 2 years

    Measured: Through 2 years post-procedure

  12. Incidence of serious adverse events (SAE) at 30 days, 6 months, 1 year, and 2 years

    Measured: Through 2 years post-procedure

Timeline

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

  1. First posted25 Oct 2022
  2. Study startNov 2022 (estimated)
  3. Primary completionNov 2023 (estimated)
  4. Study completionMay 2025 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05593224
Sponsor's protocol ID
ZHTQ 202201
Status last verified
Oct 2022
First submitted
20 Oct 2022
Last updated
25 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Intracranial Stent (Tonbridge) in people with Intracranial Atherosclerosis, run by Ton-Bridge Medical Tech. Co., Ltd at 14 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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

Results are not available in the source record.

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

Contact Long Chen (13868091267, long.chen@ton-bridge.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of in-stent restenosis at 6 months (time frame: 6 months post-procedure). 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 NCT05593224.

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 25 Oct 2022.

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