Actively Recruiting
Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage Observational Study
Led by University of Louisville · Updated on 2026-05-11
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients who have experienced a severe brain bleed caused by an aneurysm, specifically aneurysmal subarachnoid hemorrhage (aSAH). It explores a treatment approach called dome protection, which is minimally invasive and aims to prevent the aneurysm from re-bleeding. The study collects data on this approach to better understand its safety and effectiveness for patients with severe brain bleeds due to aneurysms. The dome protection method involves placing small coils to cover the fragile part of the aneurysm, instead of immediate extensive surgery. This allows patients to stabilize before undergoing full aneurysm repair. The study follows patients receiving this treatment to monitor the procedure's success, complications, and whether it prevents re-rupture of the aneurysm. Participants are observed for up to 90 days after the procedure to track aneurysm re-rupture using head CT scans or scans after neurological changes. Functional outcomes and procedural complications are also measured around 90 days post-procedure. The study aims to gather detailed data on these outcomes to help improve treatment options and patient safety for those with severe aneurysmal subarachnoid hemorrhage.
CONDITIONS
Brief Title
Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- CT confirmed aneurysmal subarachnoid hemorrhage with angiographically detected aneurysm
- WFNS aSAH grade 3 to 5 aneurysm
- Legally authorized representative available and provides consent within 72 hours after onset or last known normal
You will not qualify if you...
- Aneurysm judged suitable for balloon-assisted coiling
- Aneurysm bleeding from the neck
- Clinically judged to suffer imminent death within 24 hours
- Pregnancy or positive urine pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 72 hours after onset or last known normal
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo the dome protection procedure, a minimally invasive coil placement to stabilize the aneurysm.
1 visit (in-person)
Duration - Up to 90 days post procedure
Participants are monitored for aneurysm re-rupture and procedural complications through follow-up imaging and neurological assessments.
Regular imaging and neurological assessments as needed, including surveillance head CTs
Trial Site Locations
Total: 1 location
1
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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