Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage
NCT ID: NCT07250958
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
30 participants
OBSERVATIONAL
2026-01-31
2027-01-31
Brief Summary
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Detailed Description
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* (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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 is bleeding from the "neck"
* Patients who are clinically judged to suffer imminent death within 24 hours.
* Pregnancy or positive urine pregnancy test
18 Years
ALL
No
Sponsors
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University of Louisville
OTHER
Responsible Party
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Akshitkumar MIstry
Assistant Professor Term
Other Identifiers
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25.0321
Identifier Type: -
Identifier Source: org_study_id
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