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โ† Trials
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Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

Recruitingn/aAges 18 Years - 80 YearsAllThe Affiliated Hospital of Qingdao University
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In plain words

What the trial is, and whether it could suit you

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%).

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 and โ‰ค80 years; * Symptomatic intracranial atherosclerotic stenosis patients with ineffective medical treatment; * Digital subtraction angiography (DSA) shows target lesion stenosis โ‰ฅ70%; * 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. Exclusion Criteria: * Modified Rankin Scale (mRS) score โ‰ฅ3; * 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.
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What it tests

  • Not listed
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Where

1 site
Qingdao University Affiliated Hospital
Qingdao, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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