NCT07250958

Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage

Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage Observational Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The DOME study is a clinical trial exploring a new treatment approach for patients who suffered a severe brain bleed due to an aneurysm.

Detailed description

To prospectively capture data of patients treated with the guideline-recommended, standard-of-care dome-protection approach. The data will be used to determine: * (Primary) Incidence of aneurysm re-rupture by 90 days, censored at the time of definitive aneurysm treatment or death, detected on a surveillance head CT or one obtained after a neurological decline. * (Secondary) Measure functional status of patients around 90 days (+/- 14 days) * (Secondary) Measure success of dome protection as determined by angiographic criteria and procedural complications DOME protection is a treatment approach for patients who suffered a severe brain bleed due to an aneurysm. Instead of performing immediate, extensive surgery, this study investigates a minimally invasive procedure called "dome protection", which involves placing tiny coils to patch the most fragile part of the aneurysm. This method aims to prevent re-bleeding and allow the patient to stabilize before undergoing full aneurysm repair. The findings could lead to improved health outcomes in patients with aneurysmal subarachnoid hemorrhage by reducing procedure-related risks.

Conditions

• Aneurysmal Subarachnoid Hemorrhage

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-11-26
• Last updated: 2025-12-15