Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
1 other identifier
interventional
100
1 country
1
Brief Summary
The study evaluates the clinical and imaging outcome of middle meningeal artery (MMA) embolization with liquid embolic agent for treatment of chronic subdural hematoma (CSDH)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 29, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedMay 19, 2023
May 1, 2023
3.4 years
September 29, 2020
May 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of CSDH regression
Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization
60 dyas
Secondary Outcomes (7)
Incidence of CSDH progression or recurrence
60 days
Incidence of new neurological deficit (ND)
60 days
incidence of Death
60 days
Incidence of new ischemic stroke
60 days
Incidence of myocardial infarction/myocardial ischemia
60 days
- +2 more secondary outcomes
Study Arms (1)
Embolization arm
EXPERIMENTALIntervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil
Interventions
embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)
Eligibility Criteria
You may qualify if:
- patients diagnosed chronic or subacute subdural hematoma
- Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ...
- Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment
You may not qualify if:
- presentation with coma (GCS =\< 8)
- patients needs emergent evacuation of hematoma,
- patients could not participate in 60 days follow-up
- pregnant patients
- acute subdural hematoma
- contraindication to contrast
- contradiction to angiography
- difficult access to MMA due to anatomical variation
- contraindication to liquid embolic agent
- unmanaged/uncontrollable bleeding disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ghaem Hospital, Mashhad University of Medical Sciences
Mashhad, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Humain Baharvahdat, MD
Department of Neurosurgery, Mashhad University of Medical Sciences, Mashhad, Iran
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 29, 2020
First Posted
October 5, 2020
Study Start
August 1, 2020
Primary Completion
December 31, 2023
Study Completion
March 31, 2024
Last Updated
May 19, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share