Aneurysmal Subarachnoid HemorrhageDOMENCT07250958
Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years or older with CT confirmed aSAH with an angiographically detected aneurysm
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Louisville Hospital
Louisville, Kentucky, 40202
Mechelle Kaufman, BSN, 502-852-1513, mechelle.kaufman@louisville.edu
Akshitkumar Mistry, mD, a.mistry@uoflhealth.org
About this study
Official title: Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage Observational Study
The DOME study is a clinical trial exploring a new treatment approach for patients who suffered a severe brain bleed due to an aneurysm.
Read the 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
- Medical subject headings
- Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-rupture incidence
Detected on head CT
Measured: From procedure to 90-days post procedure.
Secondary outcomes (3)
Functional Outcome
Measured on Modified Rankin Scale (MRS) Scored 0-6 where 0-No disability, 1=no significant disability, 2= slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability, 6=dead. The higher the score the worse the outcome.
Measured: 90 days (+-14 days) post procedure
Accomplishment of Dome protection
Based on angiographic goals: 1) partial coil obliteration of the aneurysm dome or increased contrast stasis within the aneurysm dome compared to pre-embolization angiography, 2) filling of the aneurysm neck, 3) no filling of the aneurysm dome wall, and 4) no filling of the aneurysm rupture site or extra-aneurysmal contrast extravasation.
Measured: From procedure through 90-days post procedure
Procedural complications during the dome-protection and delayed final procedures on the aneurysm
Collection of adverse events.
Measured: Time of procedure through 90 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start12 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akshitkumar MIstry, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250958
- Sponsor's protocol ID
- 25.0321
- Acronym
- DOME
- Status last verified
- May 2026
- First submitted
- 18 Nov 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage Observational Study
- ClinicalTrials.gov ID
- NCT07250958
- Acronym / sponsor ID
- DOME / 25.0321
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or older with CT confirmed aSAH with an angiographically detected aneurysm
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Re-rupture incidence
Time frame: From procedure to 90-days post procedure.
Detected on head CT
3 secondary outcomes
Functional Outcome
Time frame: 90 days (+-14 days) post procedure
Accomplishment of Dome protection
Time frame: From procedure through 90-days post procedure
Procedural complications during the dome-protection and delayed final procedures on the aneurysm
Time frame: Time of procedure through 90 days post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Louisville Hospital
Louisville, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-rupture incidence (time frame: From procedure to 90-days post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.