Actively Recruiting
Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Led by The Affiliated Hospital of Qingdao University · Updated on 2026-01-20
300
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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%).
CONDITIONS
Official Title
Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Symptomatic intracranial atherosclerotic stenosis with ineffective medical treatment
- Target lesion stenosis 70% or more confirmed by digital subtraction angiography
- Suitable for rapamycin-eluting stent implantation
- Ability to understand the study and provide informed consent
You will not qualify if you...
- Modified Rankin Scale score of 3 or higher
- Ischemic stroke within the past 2 weeks
- More than 2 intracranial stenosis lesions requiring treatment
- Severe allergies to contrast agents, rapamycin, cobalt alloys, or polylactic acid
- Severe organ dysfunction such as liver, kidney, or heart failure
- Severe contraindications to heparin, aspirin, ticagrelor, clopidogrel, or other antiplatelet drugs
- Pregnant or lactating women
- Participation in other drug or device studies without completed endpoints
- Life expectancy less than 12 months
- Lesions or vascular access unsuitable for stent implantation based on operator assessment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Qingdao University Affiliated Hospital
Qingdao, Shandong, China
Actively Recruiting
Research Team
Y
Yong Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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