Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Intracranial Arterial Stenosis, Brain Diseases. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Rapamycin-eluting Vertebral Stents in the Real-world Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Overview
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%).
Primary outcome measures
- Incidence of any stroke or death within 1 month after the procedure [Time frame: 1 month]
Secondary outcome measures (6)
- Incidence of in-stent restenosis (stenosis degree >50%) at 1year (imaging subgroup) [Time frame: 1 year]
- Immediate techenical success rate of stent implantation (imaging subgroup) [Time frame: immediately after the intervention]
- Incidence of stroke or neurogenic death within 1-year follow-up [Time frame: 1 year]
- Incidence of target vessel-related stroke or death within 1-year follow-up [Time frame: 1 year]
- All-cause mortality within 1-year follow-up [Time frame: 1 year]
- mRS score at 1-year follow-up [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Qingdao University Affiliated Hospital — Qingdao
Identifiers
NCT: NCT07352852 · Bridge-2024-04-CIP-01