NCT07352852

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-05-14
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: China