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Clinical Trials in China / NCT05757505
Recruiting Not applicable

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

NCT05757505 · tracked via the Priya Life Science China tracker
Sponsor
Ton-Bridge Medical Tech. Co., Ltd
Phase
Not applicable
Started
2023-05-11
Last updated
2026-01-02

Condition(s) studied

Intracranial Atherosclerosis

Investigational drug(s) / intervention(s)

Intracranial Stent (Tonbridge)Wingspan Stent System (Stryker Neurovascular)

Intracranial Stent (Tonbridge): Endovascular treatment with Intracranial Stent (Tonbridge).

Wingspan Stent System (Stryker Neurovascular): Endovascular treatment with Wingspan Stent System (Stryker Neurovascular).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
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: * 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.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
The First Affiliated Hospital of Henan Science & Technology University Luoyang Henan Not Yet Recruiting
Zhongnan Hospital of Wuhan University Wuhan Hubei Not Yet Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Not Yet Recruiting
Jiangxi Provincial People's Hospital Nanchang Jiangxi Recruiting
The First Hospital of Jilin University Changchun Jilin Recruiting
The First Affiliated Hospital of Dalian Medical University Dalian Liaoning Recruiting
Baotou City Central Hospital Baotou Neimenggu Recruiting
First Affiliated Hospital of Kunming Medical University Kunming Yunnan Not Yet Recruiting
Hangzhou First People's Hospital Hangzhou Zhejiang Recruiting
Ningbo First Hospital Ningbo Zhejiang Recruiting
Changhai Hospital of Shanghai Shanghai China Not Yet Recruiting
Shanghai Fourth People's Hospital Shanghai China Recruiting
Tongji Hospitai of Tongji University Shanghai China Not Yet Recruiting

More Ton-Bridge Medical Tech. Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05757505 on ClinicalTrials.gov ↗ ← All trials in China