Dome-only coiling for severe aneurysmal subarachnoid hemorrhage
Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage Observational Study
This will test a minimally invasive dome-protection coiling procedure to prevent re-bleeding in adults who have had a severe aneurysmal subarachnoid hemorrhage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT07250958 on ClinicalTrials.gov |
What this trial studies
This prospective observational study will collect data on adults with CT-confirmed aneurysmal subarachnoid hemorrhage treated with the guideline-recommended dome-protection coiling approach at a single center. Eligible patients are those with an angiographically confirmed aneurysm and WFNS grade 3–5 who provide consent via a legally authorized representative within 72 hours of hemorrhage. The primary outcome is the incidence of aneurysm re-rupture within 90 days, censored at definitive aneurysm treatment or death and detected on surveillance head CT or after neurologic decline. Secondary outcomes include 90-day functional status and angiographic measures of dome protection success and procedural complications, and the protocol is observational without randomization.
Who should consider this trial
Good fit: Adults (≥18) with CT-confirmed aneurysmal subarachnoid hemorrhage, an angiographically identified aneurysm, WFNS grade 3–5, and consent via a legally authorized representative within 72 hours are the ideal candidates.
Not a fit: Patients whose aneurysm bleeds from the neck, those judged appropriate for balloon-assisted coiling, those expected to die within 24 hours, or pregnant patients are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, dome protection could reduce early re-bleeding and lower immediate procedure-related risks, allowing safer stabilization before definitive aneurysm repair.
How similar studies have performed: Small case series and retrospective reports have suggested dome-protection or partial/coiling approaches can reduce early rebleeding, but prospective multicenter evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * CT confirmed aSAH with an angiographically detected aneurysm * World Federation of Neurological Sciences (WFNS) aSAH grade 3-5 aneurysm * LAR available and gives consent within 72 hours after the onset of aSAH (or last known normal Exclusion Criteria: * Patients whose aneurysm judged appropriate for balloon-assisted coiling * Patients whose aneurysm is bleeding from the "neck" * Patients who are clinically judged to suffer imminent death within 24 hours. * Pregnancy or positive urine pregnancy test
Where this trial is running
Louisville, Kentucky
- University of Louisville Hospital — Louisville, Kentucky, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.