Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage (DOME)

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.

Study Overview

• Status: Recruiting
• Conditions: Aneurysmal Subarachnoid Hemorrhage

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville Hospital
      • Contact: Akshitkumar Mistry, mD; Email: a.mistry@uoflhealth.org
      • Principal Investigator: Akshitkumar Mistry, MD
      • Contact: Mechelle Kaufman, BSN; Phone Number: 502-852-1513; Email: mechelle.kaufman@louisville.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-rupture incidence	Detected on head CT	From procedure to 90-days post procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From procedure through 90-days post procedure
Procedural complications during the dome-protection and delayed final procedures on the aneurysm	Collection of adverse events.	Time of procedure through 90 days post procedure
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.	90 days (+-14 days) post procedure

Collaborators and Investigators

• Sponsor: University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Subarachnoid Hemorrhage
• Other Study ID Numbers: 25.0321

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No