Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT07250958

Last Updated: 2025-12-15

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-01-31

Brief Summary

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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

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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

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Aneurysmal Subarachnoid Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Akshitkumar MIstry

Assistant Professor Term

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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25.0321

Identifier Type: -

Identifier Source: org_study_id

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