The Efficacy and Safety of the Intracranial Stent (Tonbridge) in Endovascular Treatment of Intracranial Atherosclerotic Stenosis: A Prospective, Multicenter, Single-Arm Trial

Zhuhai Tonbridge Medical Tech. Co., Ltd.14 sites in 1 country156 target enrollmentNovember 2022

ConditionsIntracranial Atherosclerosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Intracranial Atherosclerosis
Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
Enrollment: 156
Locations: 14
Primary Endpoint: Incidence of in-stent restenosis at 6 months
Status: Not Yet Recruiting
Last Updated: 3 years 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 intracranial atherosclerotic stenosis.

Detailed Description

This is a prospective, multicenter, single-arm clinical trial carried out in 14 centers throughout China. 156 subjects with intracranial atherosclerotic stenosis will be treated with the Intracranial Stent (Tonbridge) 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 intracranial atherosclerotic stenosis.

Registry

clinicaltrials.gov

Start Date

November 2022

End Date

May 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhuhai Tonbridge 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 in-stent restenosis at 6 months

Time Frame: 6 months post-procedure

The in-stent restenosis is defined as more than 50% stenosis within stent or distal/proximal ends (within 5 mm), and more than 20% absolute lumen loss. The degree of intracranial artery stenosis are measured qualitatively in DSA examination. WASID study will be used to measure the degree of intracranial artery stenosis.

Secondary Outcomes

Device success rate and procedural success rate(Intraoperation)
Incidence of symptomatic in-stent restenosis at 6 months, 1 year, and 2 years(6 months, 1 year, and 2 years post-procedure)
Ratio of mRS 0-2 at 30 days, 6 months, 1 year, and 2 years(30 days, 6 months, 1 year, and 2 years post-procedure)
Incidence of stent restenosis at 1 and 2 years(1 and 2 years post-procedure)
Incidence of any stroke and death within 30 days(Within 30 days post-procedure)
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 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)
The 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)
Incidence of device deficiency(After use of device to end of study)
Incidence of adverse events (AE) at 30 days, 6 months, 1 year, and 2 years(Through 2 years post-procedure)
Incidence of serious adverse events (SAE) at 30 days, 6 months, 1 year, and 2 years(Through 2 years post-procedure)