Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Rapamycin-eluting Vertebral Stents in the Real-world Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
The Affiliated Hospital of Qingdao University
300 participants
May 14, 2025
OBSERVATIONAL
Conditions
Summary
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%).
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07352852