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RecruitingNCT07250958DOMEUpdated May 11, 2026

Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage

An observational study in Aneurysmal Subarachnoid Hemorrhage, sponsored by University of Louisville. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by University of Louisville · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 149 studies in Subarachnoid Hemorrhage with a site in United States — 31 open to participants now, 37 under way, 2 of them phase 3. Subarachnoid Hemorrhage · United States.

Planned enrollment
30th of 42
30 · median 60
Started
2026
with 7 others
Observational
42 of 149
12 open now
Primary completion
2027-01
later than 13 of 36 live
Registered
143rd of 149
by date

Among the 149 studies in Subarachnoid Hemorrhage with a site in United States, this one is the 30th largest by planned enrollment of the 42 observational ones that give a count, is one of 8 that started in 2026, is one of 42 observational ones, reaches primary completion later than 13 of the 36 other live ones, and was the 143rd registered.

Subarachnoid Hemorrhage

510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.

Browse Subarachnoid Hemorrhage studies →

Open to participants now

31 of the 149 studies in Subarachnoid Hemorrhage with a site in United States are open now. Recruiting first, the newest first:

25 more — sign in →

All 31 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 89 Subarachnoid Hemorrhage studies recruiting now, 56 (63%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Aneurysmal Subarachnoid Hemorrhage
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients 18 years or older with CT confirmed aSAH with an angiographically detected aneurysm

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Re-rupture incidence

    Detected on head CT

    Time frame: From procedure to 90-days post procedure.

Secondary outcomes

  1. 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.

    Time frame: 90 days (+-14 days) post procedure

  2. 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.

    Time frame: From procedure through 90-days post procedure

  3. Procedural complications during the dome-protection and delayed final procedures on the aneurysm

    Collection of adverse events.

    Time frame: Time of procedure through 90 days post procedure

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Jan 2027, 10 months after the start.

Of 116 non-industry observational studies under Subarachnoid Hemorrhage, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 127. This study's planned 10 months is below that.

Counting every sponsor, half of 119 studies reached it within 40 months; a quarter within 19 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2025
First posted
Nov 26, 2025
StartActual
Mar 12, 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
May 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07250958
Responsible party
Akshitkumar MIstry (Assistant Professor Term, University of Louisville) — Principal investigator
First posted
Nov 26, 2025
Start date
Mar 12, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
May 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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