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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Intracranial Stent (Tonbridge)
  Endovascular treatment with Intracranial Stent (Tonbridge).
• Устройство Wingspan Stent System (Stryker Neurovascular)
  Endovascular treatment with Wingspan Stent System (Stryker Neurovascular).

Первичные конечные точки

• Incidence of any stroke and death within 30 days [Срок оценки: 30±7 days post-procedure]

Вторичные конечные точки (12)

• Incidence of in-stent restenosis at 6 months, 12 months, and 24 months [Срок оценки: 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 [Срок оценки: 6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure]
• Device success rate [Срок оценки: intra-procedure]
• Procedural success rate [Срок оценки: intra-procedure]
• Ratio of mRS 0-2 at 30 days, 6 months, 12 months, and 24 months [Срок оценки: 30±7 days, 6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure]
• Mortality at 31 days to 6 months, 6 to 12 months, and 12 to 24 months [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure]
• Incidence of device deficiency [Срок оценки: After use of device to end of study, assess up to 24 months]
• Incidence of adverse events (AE) at 30 days, 6 months, 12 months, and 24 months [Срок оценки: Through 24 months post-procedure]
• Incidence of serious adverse events (SAE) at 30 days, 6 months, 12 months, and 24 months [Срок оценки: Through 24 months post-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 13 центров

• The First Affiliated Hospital of Henan Science ＆ Technology University — Luoyang
• Zhongnan Hospital of Wuhan University — Ухань
• Nanjing Drum Tower Hospital — Нанкин
• Jiangxi Provincial People's Hospital — Nanchang
• The First Hospital of Jilin University — Changchun
• The First Affiliated Hospital of Dalian Medical University — Dalian
• Baotou City Central Hospital — Baotou
• First Affiliated Hospital of Kunming Medical University — Куньмин
• … и ещё 5 центров

Идентификаторы

NCT: NCT05757505 · ZHTQ 202203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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