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

NCT07352852 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-01-20

No results posted yet for this study

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%).

Conditions

  • Intracranial Arterial Stenosis
  • Brain Diseases

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07352852 on ClinicalTrials.gov