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NCT Number: NCT07250958

Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage

The DOME study is a clinical trial exploring a new treatment approach for patients who suffered a severe brain bleed due to an aneurysm.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location status: Recruiting

Location contact

Akshitkumar Mistry, MD

PRINCIPAL_INVESTIGATOR

Akshitkumar Mistry, mD

CONTACT

[email protected]

Mechelle Kaufman, BSN

CONTACT

[email protected]

502-852-1513

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Re-rupture incidence

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

    Detected on head CT

Secondary outcomes

  1. Functional Outcome

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

    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.

  2. Accomplishment of Dome protection

    Time frame: From procedure through 90-days post procedure

    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.

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

    Time frame: Time of procedure through 90 days post procedure

    Collection of adverse events.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage Observational Study

Acronym: DOME

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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