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

Ton-Bridge Medical Tech. Co., Ltd13 sites in 1 country200 target enrollmentMay 11, 2023

ConditionsIntracranial Atherosclerosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Intracranial Atherosclerosis
Sponsor: Ton-Bridge Medical Tech. Co., Ltd
Enrollment: 200
Locations: 13
Primary Endpoint: Incidence of any stroke and death within 30 days
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

May 11, 2023

End Date

December 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ton-Bridge Medical Tech. Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Incidence of any stroke and death within 30 days

Time Frame: 30±7 days post-procedure

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

Secondary Outcomes

Procedural success rate(intra-procedure)
Incidence of serious adverse events (SAE) at 30 days, 6 months, 12 months, and 24 months(Through 24 months post-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)
Incidence of ischemic stroke in non-target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months(31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure)
Incidence of adverse events (AE) at 30 days, 6 months, 12 months, and 24 months(Through 24 months post-procedure)
Device success rate(intra-procedure)
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)
Incidence of device deficiency(After use of device to end of study, assess up to 24 months)
Mortality at 31 days to 6 months, 6 to 12 months, and 12 to 24 months(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(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(31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure)