Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

Официальное название

Rapamycin-eluting Vertebral Stents in the Real-world Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

Обзор

This clinical trial is a prospective, multicenter, single-arm study. About 300 subjects undergoing rapamycin-eluting stent implantation will be enrolled based on the inclusion and exclusion criteria. The primary endpoint is the rate of any stroke or death within 1 month. Secondary efficacy endpoints include immediate stent implantation success. Safety endpoints cover the incidence of stroke or neurological death, target-vessel-related stroke or death, all-cause mortality, and mRS scores at 12-month follow-ups. Subjects will be clinically followed up before surgery, device implantation, discharge, and at 1, 6, and 12 months post-surgery. An imaging subgroup of at least 80 subjects who agree to DSA follow-up at 12 months will assess in-stent restenosis (\>50%).

Первичные конечные точки

• Incidence of any stroke or death within 1 month after the procedure [Срок оценки: 1 month]

Вторичные конечные точки (6)

• Incidence of in-stent restenosis (stenosis degree >50%) at 1year (imaging subgroup) [Срок оценки: 1 year]
• Immediate techenical success rate of stent implantation (imaging subgroup) [Срок оценки: immediately after the intervention]
• Incidence of stroke or neurogenic death within 1-year follow-up [Срок оценки: 1 year]
• Incidence of target vessel-related stroke or death within 1-year follow-up [Срок оценки: 1 year]
• All-cause mortality within 1-year follow-up [Срок оценки: 1 year]
• mRS score at 1-year follow-up [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age ≥18 and ≤80 years;
• Symptomatic intracranial atherosclerotic stenosis patients with ineffective medical treatment;
• Digital subtraction angiography (DSA) shows target lesion stenosis ≥70%;
• Suitable for implantation of rapamycin-targeted drug-eluting stents;
• The patient and/or their authorized representative can understand the study purpose, agree to participate, and sign the informed consent form.

Критерии исключения

• Modified Rankin Scale (mRS) score ≥3;
• Ischemic stroke within the past 2 weeks;
• Presence of more than 2 intracranial atherosclerotic stenosis lesions requiring interventional treatment;
• Severe contraindications to heparin, aspirin, ticagrelor, clopidogrel, or other antiplatelet drugs, and inability to tolerate anticoagulant/antiplatelet therapy;
• Severe dysfunction of major organs (e.g., severe hepatic insufficiency, renal insufficiency, heart failure);
• Severe allergies to contrast agents, rapamycin and its derivatives, cobalt-based alloys, or polylactic acid;
• Pregnant or lactating women;
• Participation in other drug or device studies without reaching the endpoint;
• Life expectancy less than 12 months;
• Lesions or vascular access deemed unsuitable for rapamycin drug-eluting stent implantation by the operator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Qingdao University Affiliated Hospital — Qingdao

Идентификаторы

NCT: NCT07352852 · Bridge-2024-04-CIP-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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