NCT06174727

International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)

Outcomes of Intra-arterial and Endosaccular Flow Diverters for Treatment of Intracranial Aneurysms - International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.

Detailed description

Flow diverters and endosaccular flow disruptors used for the treatment of intracranial aneurysms exhibit distinct procedural and clinical outcomes, with potential differences in device-specific parameters such as procedure time, radiation exposure, adjunct device requirements, and long-term angiographic success. Since the completion of the Pipeline Embolization Device (PED) for the Intracranial Treatment of Aneurysms trial, the field of flow diversion has undergone continuous evolution with the development and approval of several devices. While these devices share a similar mechanism for aneurysm occlusion, their design and delivery systems can vary significantly. Various studies have demonstrated a promising safety and efficacy profile; however, the available data for a direct comparison of the technical and clinical outcomes between these devices remains limited.

Conditions

• Intracranial Aneurysm

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-12-18
• Last updated: 2026-01-07

Locations

11 sites across 2 countries: United States, Canada