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

NCT05757505 | Recruiting

• 1 other identifier: ZHTQ 202203
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Intracranial Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Incidence of any stroke and death within 30 days

  Stroke includes both ischemic and hemorrhagic stroke. Death includes death due to any cause.

  30±7 days post-procedure

Secondary Outcomes (12)

• Incidence of in-stent restenosis at 6 months, 12 months, and 24 months

  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

  6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure

• Device success rate

  intra-procedure

• Procedural success rate

  intra-procedure

• Ratio of mRS 0-2 at 30 days, 6 months, 12 months, and 24 months

  30±7 days, 6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure

Study Arms (2)

experimental group

EXPERIMENTAL

Intracranial Stent (Tonbridge)

Device: Intracranial Stent (Tonbridge)

control group

ACTIVE COMPARATOR

Wingspan Stent System (Stryker Neurovascular)

Device: Wingspan Stent System (Stryker Neurovascular)

Interventions

Intracranial Stent (Tonbridge) DEVICE

Endovascular treatment with Intracranial Stent (Tonbridge).

experimental group

Wingspan Stent System (Stryker Neurovascular) DEVICE

Endovascular treatment with Wingspan Stent System (Stryker Neurovascular).

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ton-Bridge Medical Tech. Co., Ltd: lead

Study Sites (13)

The First Affiliated Hospital of Henan Science ＆ Technology University

Luoyang, Henan, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

Baotou City Central Hospital

Baotou, Neimenggu, China

RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

NOT YET RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

Ningbo First Hospital

Ningbo, Zhejiang, China

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

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianmin Liu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Shouchun Wang

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Long Chen

CONTACT

13868091267; long.chen@ton-bridge.com

Yuhan Yan

CONTACT

15843291055; yh.yan@ton-bridge.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 7, 2023
• Study Start: May 11, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-04

Locations

CN (13)