Actively Recruiting
The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Led by Ton-Bridge Medical Tech. Co., Ltd · Updated on 2026-01-02
200
Participants Needed
13
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 18-75
- Symptomatic intracranial atherosclerotic stenosis unresponsive to antiplatelet therapy or with poor collateral circulation and hypoperfusion
- Last onset of transient ischemic attack is unrestricted or ischemic stroke occurred more than 2 weeks ago
- Lesion located in intracranial large arteries: internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery
- Target vessel diameter between 2.0mm and 4.5mm, lesion length up to 33mm
- Stenosis degree between 70% and 99% measured by intracranial angiography (WASID method)
- Single intracranial artery stenosis requiring intervention
- At least one atherosclerotic risk factor such as hypertension, diabetes, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, or smoking history
- Modified Rankin Scale score 2 or less before enrollment
- Voluntary participation with ability to complete study examinations and follow-ups
You will not qualify if you...
- Intracranial arterial stenosis caused by non-atherosclerotic conditions like arterial dissection, moyamoya disease, vasculitis, or active arteritis
- Only perforator infarction in target lesion on preoperative MRI
- Post-infarct hemorrhagic transformation in target vessel or history of certain brain hemorrhages within 30 days prior
- Severe calcification or vessel tortuosity preventing device delivery
- More than 70% stenosis in other intracranial large vessels near target vessel or unidentified lesions
- Major surgery within 30 days before procedure or planned hospitalization for other procedures within 6 months
- Intracranial tumors, arteriovenous malformations, or aneurysms near target vessels
- Target lesion with prior stent implantation
- Severe allergy or contraindication to related drugs or devices
- Cardiac thrombus sources such as atrial fibrillation or recent myocardial infarction within 30 days
- Elevated INR greater than 1.5 or bleeding disorders
- Medically uncontrolled severe hypertension
- Severe or unstable heart, lung, kidney, or liver failure, or malignancy
- Life expectancy less than two years
- Pregnant or breastfeeding women
- Cognitive impairment, mood disorders, or mental illness preventing follow-up
- Enrollment in other clinical trials without meeting primary endpoints
- Any other condition deemed inappropriate for stent treatment by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Y
Yuhan Yan
CONTACT
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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