NCT06614972

Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry)

Clinical Outcome of Balloon-Expandable Drug-Eluting Stenting For Patients With Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Real-World Registry Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 520 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To study the clinical outcomes after implantation of balloon-expandable drug-eluting stents in patients with symptomatic intracranial atherosclerotic stenosis in prevention of composite event of any stroke and death within 30 days and ischemic stroke in the territories of the responsible artery from 31 days to 1-year.

Detailed description

This study is a prospective, multi-center, real world, registry study. This study aimed to evaluate the effectiveness of balloon-expandable drug-eluting stents in treating stenosis in the C2-C7 segments of the internal carotid artery and V4 artery which with high prevalence of calcified plaques in ICAD.

Conditions

• Atheroscleroses, Cerebral
• Intracranial Atherosclerosis
• Ischemia Stroke

Interventions

Type	Name	Description
DEVICE	Balloon-expandable drug-eluting stent	Balloon-expandable drug-eluting stent (BDES) is the device comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.

Timeline

• Start date: 2024-09-30
• Primary completion: 2025-09-30
• Completion: 2030-09-30
• First posted: 2024-09-26
• Last updated: 2024-09-26