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

Zhuhai Tonbridge Medical Technology

Status

Not yet enrolling

Conditions

Intracranial Atherosclerosis

Treatments

Device: Intracranial Stent (Tonbridge)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05593224

ZHTQ 202201

Details and patient eligibility

About

The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of intracranial atherosclerotic stenosis.

Full 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.

Enrollment

156 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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