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Not yet recruitingNCT05593224Updated Oct 25, 2022

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

An interventional study of Intracranial Stent (Tonbridge) in Intracranial Atherosclerosis, sponsored by Zhuhai Tonbridge Medical Tech. Co., Ltd.. Not yet recruiting at 14 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-25.

Sponsored by Zhuhai Tonbridge Medical Tech. Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Intracranial Atherosclerosis
03

In context

Intracranial Arteriosclerosis

93 studies on the registry are indexed under Intracranial Arteriosclerosis; 41 are open to participants now.

This study's planned enrollment of 156 is below the median of 194 across 55 interventional studies indexed under Intracranial Arteriosclerosis.

Browse Intracranial Arteriosclerosis studies →

Lead sponsor

Zhuhai Tonbridge Medical Tech. Co., Ltd. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
156 participants (estimated)

Study arms

  • Experimental
    Intracranial Stent (Tonbridge)

    Placement of Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd. ).

    Device: Intracranial Stent (Tonbridge)

Interventions

  • DeviceIntracranial Stent (Tonbridge)

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 6 months post-procedure

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Within 30 days post-procedure

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: After use of device to end of study

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

    Time frame: Through 2 years post-procedure

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

    Time frame: Through 2 years post-procedure

07

Study locations

14 sites
  • The First Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
    • Conghui Li · Principal investigator
  • The First Affiliated Hospital of Henan Science ＆ Technology University
    Luoyang, Henan, China
    • Jisheng Qi · Principal investigator
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei, China
  • Nanjing Drum Tower Hospital
    Nanjing, Jiangsu, China
    • Yun Xu · Principal investigator
  • Jiangxi Provincial People's Hospital
    Nanchang, Jiangxi, China
    • Wenfeng Cao · Principal investigator
  • The First Hospital of Jilin University
    Changchun, Jilin, China
    • Shouchun Wang · Principal investigator
  • The First Affiliated Hospital of Dalian Medical University
    Dalian, Liaoning, China
    • Feng Wang · Principal investigator
  • Baotou City Central Hospital
    Baotou, Neimenggu, China
    • Changchun Jiang · Principal investigator
  • Affiliated Hospital of Jining Medical University
    Jining, Shandong, China
    • Yongnan Hao · Principal investigator
  • First Affiliated Hospital of Kunming Medical University
    Kunming, Yunnan, China
    • Chun Chen · Principal investigator
  • Hangzhou First People's Hospital
    Hangzhou, Zhejiang, China
    • Congguo Yin · Principal investigator
  • Ningbo First Hospital
    Ningbo, Zhejiang, China
    • Zhiqing Lin · Principal investigator
  • Changhai Hospital of Shanghai
    Shanghai, China
    • Jianmin Liu · Principal investigator
  • Tongji Hospitai of Tongji University
    Shanghai, China
    • Chun Fang · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05593224
Lead sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
Responsible party
Sponsor
First posted
Oct 25, 2022
Start date
Nov 2022 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
May 2025 (estimated)
Last update
Oct 25, 2022

Study contacts

Long Chen
Contact
long.chen@ton-bridge.com
13868091267
Yuhan Yan
Contact
yh.yan@ton-bridge.com
15843291055
Jianmin Liu
principal investigator · Changhai Hospital
Shouchun Wang
principal investigator · The First Hospital of Jilin University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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