Intracranial AtherosclerosisNCT05757505
The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
A study testing Intracranial Stent (Tonbridge) and Wingspan Stent System (Stryker Neurovascular) in people with Intracranial Atherosclerosis, run by Ton-Bridge Medical Tech. Co., Ltd at 13 sites in China.
Trial summary
The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of symptomatic 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) and Wingspan Stent System (Stryker Neurovascular)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 13 sitesChina
- Study dates
- 11 May 2023to Dec 2026
- Phase
- Interventional
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
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Baotou City Central Hospital
Baotou, Neimenggu
Changchun Jiang
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Shouchun Wang
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Feng Wang
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Congguo Yin
- Not yet recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Chun Chen
- Not yet recruiting
The First Affiliated Hospital of Henan Science ＆ Technology University
Luoyang, Henan
Jisheng Qi
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
Wenfeng Cao
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Yun Xu
- Recruiting
Ningbo First Hospital
Ningbo, Zhejiang
Shengjun Zhou
- Not yet recruiting
Changhai Hospital of Shanghai
Shanghai
Jianmin Liu
- Recruiting
Shanghai Fourth People's Hospital
Shanghai
Yibin Fang
- Not yet recruiting
Tongji Hospitai of Tongji University
Shanghai
Chun Fang
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Yumin Liu
About this study
Official title: The Efficacy and Safety of the Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of symptomatic intracranial atherosclerotic stenosis.
Read the detailed description
This is a prospective, multicenter, randomized controlled, non-inferiority clinical trial carried out in 13 centers throughout China. 200 subjects with symptomatic intracranial atherosclerotic stenosis will be treated with the Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) or the Wingspan Stent System (Stryker Neurovascular) 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 symptomatic intracranial atherosclerotic stenosis.
- Conditions
- Intracranial Atherosclerosis
- Being tested
- Intracranial Stent (Tonbridge), Wingspan Stent System (Stryker Neurovascular)
- 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
Endovascular treatment with Intracranial Stent (Tonbridge).
Wingspan Stent System (Stryker Neurovascular)Device
Endovascular treatment with Wingspan Stent System (Stryker Neurovascular).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Intracranial Stent (Tonbridge) Receives: Device: Intracranial Stent (Tonbridge) |
| control group | Active comparator | Wingspan Stent System (Stryker Neurovascular) Receives: Device: Wingspan Stent System (Stryker Neurovascular) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any stroke and death within 30 days
Stroke includes both ischemic and hemorrhagic stroke. Death includes death due to any cause.
Measured: 30±7 days post-procedure
Secondary outcomes (12)
Incidence of in-stent restenosis at 6 months, 12 months, and 24 months
ISR was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss. The degree of intracranial artery stenosis will be measured qualitatively in DSA or CTA examination with WASID method.
Measured: 6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure
Incidence of symptomatic in-stent restenosis at 6 months, 12 months, and 24 months
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±60 days, 12 months±30 days, and 24 months±30 days post-procedure
Device success rate
Device success refers to the successful delivery of the stent to the lesion site through the delivery system during procedure, and the stent is deployed well without bending and displacement.
Measured: intra-procedure
Procedural success rate
Procedural success is defined as stenosis degree less than 30% immediately after procedure.
Measured: intra-procedure
Ratio of mRS 0-2 at 30 days, 6 months, 12 months, and 24 months
Subjects will be evaluated at the follow-up visits with mRS. mRS 0-2 indicates a good prognosis.
Measured: 30±7 days, 6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure
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
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
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
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
Incidence of device deficiency
Device deficiency is the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions. Possible device deficiency: labeling errors, product quality problems, design defects, broken sterilization packaging, etc.
Measured: After use of device to end of study, assess up to 24 months
Incidence of adverse events (AE) at 30 days, 6 months, 12 months, and 24 months
Measured: Through 24 months post-procedure
Incidence of serious adverse events (SAE) at 30 days, 6 months, 12 months, and 24 months
Measured: Through 24 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start11 May 2023
- Primary completionJan 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ton-Bridge Medical Tech. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin Liu, Principal investigator, Changhai HospitalShouchun Wang, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757505
- Sponsor's protocol ID
- ZHTQ 202203
- Status last verified
- Apr 2025
- First submitted
- 22 Feb 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No