Actively Recruiting
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
Led by Ton-Bridge Medical Tech. Co., Ltd · Updated on 2026-01-02
200
Participants Needed
13
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of the Intracranial Stent (Tonbridge) compared to the Wingspan Stent System in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis. This prospective, multicenter, randomized controlled trial is conducted across 13 centers in China with 200 participants who have this condition and meet specific study criteria. Participants will receive either the Intracranial Stent (Tonbridge) or the Wingspan Stent System to treat narrowed intracranial arteries. The trial aims to determine if the Tonbridge stent is not inferior to the Wingspan stent. Treatments are delivered through endovascular procedures targeting affected large arteries such as the internal carotid, middle cerebral, vertebral, or basilar arteries. During the study, participants will undergo evaluations at multiple time points up to 24 months after the procedure, including assessments of stroke and death rates within 30 days, restenosis rates at 6, 12, and 24 months, and functional outcomes measured by the modified Rankin Scale. Safety will be monitored by tracking adverse events, device success, and stroke incidence. The total study duration spans up to two years with follow-up visits to monitor health and treatment results.
CONDITIONS
Brief Title
The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Symptomatic intracranial atherosclerotic stenosis not responding to antiplatelet therapy or with poor collateral circulation and hypoperfusion
- Last ischemic stroke occurred more than 2 weeks ago or no time limit for last TIA
- Lesion located in intracranial large arteries including internal carotid, middle cerebral, vertebral, or basilar artery
- Target vessel diameter between 2.0 mm and 4.5 mm, lesion length up to 33 mm
- Degree of stenosis between 70% and 99% confirmed by intracranial angiography
- Single lesion requiring interventional treatment
- At least one atherosclerotic risk factor such as hypertension, diabetes, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, or smoking history
- Modified Rankin Scale score 0 to 2 before enrollment
- Voluntary participation with signed informed consent and ability to complete required examinations and follow-ups
You will not qualify if you...
- Intracranial arterial stenosis caused by non-atherosclerotic diseases like arterial dissection, moyamoya disease, or vasculitis
- Preoperative MRI showing only perforator infarction in the target lesion
- Recent hemorrhagic brain conditions within 30 days or untreated chronic subdural hematoma
- Severe calcification or vessel tortuosity making device delivery difficult
- More than 70% stenosis in other large intracranial or extracranial vessels related to the target vessel
- Major surgery within 30 days before procedure or planned hospitalization within 6 months after
- Intracranial tumors, arteriovenous malformations, or aneurysms near target vessels
- History of stent implantation in the target lesion
- Severe allergies or contraindications to aspirin, clopidogrel, heparin, contrast media, nitinol, or related devices
- Cardiac sources of thrombus such as atrial fibrillation or recent myocardial infarction
- INR greater than 1.5 or bleeding disorders
- Uncontrolled severe hypertension
- Severe or unstable comorbid conditions like heart, lung, kidney, liver failure, or malignancy
- Life expectancy less than two years
- Pregnant or breastfeeding women
- Cognitive impairment, mood disorder, or mental illness preventing follow-up
- Participation in other clinical trials without reaching primary endpoint
- Other investigator-determined contraindications for intracranial stent treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo endovascular treatment with either the Intracranial Stent (Tonbridge) or the Wingspan Stent System to expand the vascular stenosis site.
1 procedure visit (in-person)
Duration - Up to 24 months post-procedure
Participants are followed to monitor safety and effectiveness including incidence of stroke, restenosis, and adverse events after the stent procedure.
Visits at 30 days, 6 months, 12 months, and 24 months post-procedure
Trial Site Locations
Total: 13 locations
1
The First Affiliated Hospital of Henan Science ＆ Technology University
Luoyang, Henan, China
Not Yet Recruiting
2
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Not Yet Recruiting
3
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
4
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Actively Recruiting
5
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
6
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
7
Baotou City Central Hospital
Baotou, Neimenggu, China
Actively Recruiting
8
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Not Yet Recruiting
9
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
10
Ningbo First Hospital
Ningbo, Zhejiang, China
Actively Recruiting
11
Changhai Hospital of Shanghai
Shanghai, China
Not Yet Recruiting
12
Shanghai Fourth People's Hospital
Shanghai, China
Actively Recruiting
13
Tongji Hospitai of Tongji University
Shanghai, China
Not Yet Recruiting
Research Team
L
Long Chen
Y
Yuhan Yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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