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

Primary Purpose

Chronic Subdural Hematoma

Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Embolization of MMA
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring chronic subdural hematoma, embolization, middle meningeal artery, liquid embolic agent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghaem Hospital, Mashhad University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Embolization arm

Arm Description

Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of CSDH progression or recurrence
Increase in volume of CSDH
Incidence of new neurological deficit (ND)
ND includes: dementia, memory loss, cognitive problems, monoparesis/hemiparesis, cranial nerve paresis, dysphasia/aphasia
incidence of Death
Incidence of new ischemic stroke
new ischemia in imaging (DWI/MRI or CT scan) within 60 days of operation
Incidence of myocardial infarction/myocardial ischemia
new ischemic heart attack within 60 days of operation
Incidence of embolization complication in brain
cranial nerve palsy (especially VII), vision loss (ophthalmic/retinal artery occlusion), ...
incidence of embolization complication out of brain
puncture hematoma, major artery dissection, new renal failure, ...

Full Information

First Posted
September 29, 2020
Last Updated
May 18, 2023
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04574843
Brief Title
Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
Official Title
Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
chronic subdural hematoma, embolization, middle meningeal artery, liquid embolic agent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Embolization arm
Arm Type
Experimental
Arm Description
Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil
Intervention Type
Procedure
Intervention Name(s)
Embolization of MMA
Other Intervention Name(s)
Onyx, Squid, Phil
Intervention Description
embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)
Primary Outcome Measure Information:
Title
Incidence of CSDH regression
Description
Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization
Time Frame
60 dyas
Secondary Outcome Measure Information:
Title
Incidence of CSDH progression or recurrence
Description
Increase in volume of CSDH
Time Frame
60 days
Title
Incidence of new neurological deficit (ND)
Description
ND includes: dementia, memory loss, cognitive problems, monoparesis/hemiparesis, cranial nerve paresis, dysphasia/aphasia
Time Frame
60 days
Title
incidence of Death
Time Frame
60 days
Title
Incidence of new ischemic stroke
Description
new ischemia in imaging (DWI/MRI or CT scan) within 60 days of operation
Time Frame
60 days
Title
Incidence of myocardial infarction/myocardial ischemia
Description
new ischemic heart attack within 60 days of operation
Time Frame
60 days
Title
Incidence of embolization complication in brain
Description
cranial nerve palsy (especially VII), vision loss (ophthalmic/retinal artery occlusion), ...
Time Frame
48 hours
Title
incidence of embolization complication out of brain
Description
puncture hematoma, major artery dissection, new renal failure, ...
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Humain Baharvahdat, MD
Phone
+98-915-110-0400
Email
humainbv@yahoo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Masoud Pishjoo, MD
Phone
‭+98 915 362 8792‬
Email
masoud.pishjoo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Humain Baharvahdat, MD
Organizational Affiliation
Department of Neurosurgery, Mashhad University of Medical Sciences, Mashhad, Iran
Official's Role
Study Director
Facility Information:
Facility Name
Ghaem Hospital, Mashhad University of Medical Sciences
City
Mashhad
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Humain Baharvahdat, MD
Phone
+98-915-110-0400
Email
humainbv@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Feizollah EBRAHIMNIA, MD
First Name & Middle Initial & Last Name & Degree
Ali SHARIAT-RAZAVI, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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