Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma

• Sponsor: Mashhad University of Medical Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04574843
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Chronic Subdural Hematoma	Procedure: Embolization of MMA	N/A

Detailed Description

This study is a prospective one arm trial designed to assess the safety and efficacy of MMA embolization with liquid embolic agents (onyx/squid/Phil) as the main treatment of CSDH.

The subjects are enrolled in the study according to inclusion and exclusion criteria. Imaging and clinical presentations of patients are recorded. Within 48 hours of embolization, patients are assessed with clinical examination and with a brain CT scan to evaluate in any change in their symptoms and CSDH volume. 2-4 weeks after embolization, patients are evaluated in clinic for any change in their symptoms and signs. 60 days after embolization patients are examined clinically and are assessed for SDH volume change in CT scan and MRI.

If there is any significant increase in CSDH volume or any deterioration of patient, evacuation of hematoma is considered.

MMA embolization is performed under general anesthesia using biplane or monoplane angiography. Femoral or radial accesses are used. Guiding catheter is advanced into external carotid artery in corresponding side. The corresponding MMA is catheterized distally by micro-catheter and is embolized by liquid embolic agents. Patients are discharge next day if they are stable.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
• Actual Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Embolization arm Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil	Procedure: Embolization of MMA; embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil); Other Names: Onyx Squid Phil

Outcome Measures

Primary Outcome Measures

1. Incidence of CSDH regression [60 dyas]

   Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization

Secondary Outcome Measures

1. Incidence of CSDH progression or recurrence [60 days]

   Increase in volume of CSDH

2. Incidence of new neurological deficit (ND) [60 days]

   ND includes: dementia, memory loss, cognitive problems, monoparesis/hemiparesis, cranial nerve paresis, dysphasia/aphasia

3. incidence of Death [60 days]

4. Incidence of new ischemic stroke [60 days]

   new ischemia in imaging (DWI/MRI or CT scan) within 60 days of operation

5. Incidence of myocardial infarction/myocardial ischemia [60 days]

   new ischemic heart attack within 60 days of operation

6. Incidence of embolization complication in brain [48 hours]

   cranial nerve palsy (especially VII), vision loss (ophthalmic/retinal artery occlusion), ...

7. incidence of embolization complication out of brain [15 days]

   puncture hematoma, major artery dissection, new renal failure, ...

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. patients diagnosed chronic or subacute subdural hematoma

2. Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ...

3. Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment

Exclusion Criteria:

1. presentation with coma (GCS =< 8)

2. patients needs emergent evacuation of hematoma,

3. patients could not participate in 60 days follow-up

4. pregnant patients

5. acute subdural hematoma

6. contraindication to contrast

7. contradiction to angiography

8. difficult access to MMA due to anatomical variation

9. contraindication to liquid embolic agent

10. unmanaged/uncontrollable bleeding disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghaem Hospital, Mashhad University of Medical Sciences	Mashhad		Iran, Islamic Republic of

Sponsors and Collaborators

• Mashhad University of Medical Sciences

Investigators

• Study Director: Humain Baharvahdat, MD, Department of Neurosurgery, Mashhad University of Medical Sciences, Mashhad, Iran

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Humain Baharvahdat, Associate Professor, Mashhad University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04574843
• Other Study ID Numbers: 990631
• First Posted: Oct 5, 2020
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Humain Baharvahdat, Associate Professor, Mashhad University of Medical Sciences: chronic subdural hematoma; embolization; middle meningeal artery; liquid embolic agent
• Additional relevant MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma

Study Results

No Results Posted as of Mar 18, 2022