Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
Primary Purpose
Chronic Subdural Hematoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Middel Meningeal Artery Embolization
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Chronic Subdural Hematoma, Embolization, Middle meningeal artery
Eligibility Criteria
Inclusion Criteria:
- Age must be greater or equal to 18 years of age.
- Subjects must have a diagnosis of chronic or acute-on-chronic subdural hematoma based on brain imaging, as documented by an independent radiologist.
- One or more symptoms attributable to chronic SDH including headache, cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
- In the opinion of the site investigator or the subject's referring physician, the subject has failed conservative management.
Exclusion Criteria:
- The subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment.
- Any requirement for urgent surgical evacuation is necessary.
- Life expectancy is less than 6 months in the opinion of the subject's primary physician.
- Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram.
- Acute subdural hematomas.
- Pregnancy
Sites / Locations
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Middle Meningeal Artery Embolization
Arm Description
Outcomes
Primary Outcome Measures
Changes in neurological status after embolization of the MMA for symptomatic, chronic, and medically refractory SDH.
A neurological exam will be performed to assess any neurological changes post-procedure.
Changes in size of the SDH post-procedure.
A CT scan will be performed to assess the size of the SDH before and after the procedure.
Secondary Outcome Measures
The safety of embolization of the MMA for symptomatic, chronic, and medically refractory SDH
A neurologic exam will be performed to assess any neurological deficits and/or improvements post-procedure.
Full Information
NCT ID
NCT03307395
First Posted
September 28, 2017
Last Updated
March 2, 2021
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT03307395
Brief Title
Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
Official Title
Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach has been attempted with the goal of eliminating the arterial supply to the vascularized membrane. The investigators have recently presented the first known case series of MMA embolization as upfront treatment for cSDH in lieu of surgical evacuation (publication pending). Five patients underwent successful embolization of the MMA with subsequent reduction in size or complete resolution of cSDH with no peri-procedural complications.
The purpose of this study will be to evaluate the safety and efficacy of MMA embolization compared to traditional surgical management for symptomatic, chronic, and medically refractory SDH. MMA embolization is an established procedure used routinely for treatment of tumors or vascular malformations; this study investigates the use of an established procedure for a new disease. The investigators hypothesize that MMA embolization will afford a particularly fragile patient population an alternative to invasive and morbid neurosurgical intervention.
Detailed Description
The purpose of this study will be to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical management for symptomatic, chronic, and medically refractory subdural hematoma (SDH). MMA embolization is an established procedure used routinely for treatment of tumors or vascular malformations; this study investigates the use of an established procedure for a new disease. The investigators hypothesize that MMA embolization will afford a particularly fragile patient population an alternative to invasive and morbid neurosurgical intervention.
Since subjects being enrolled will be those that are symptomatic from chronic SDH, pre-procedural data such as clinical history, neurologic examination, and CT scans will already be available. The day after the embolization, subjects will undergo a clinical interview to assess change in symptoms. A neurologic exam and CT scan will also be performed prior to discharge. Telephone surveys will be used at intermittent time points to assess for change in clinical symptoms. The subjects will also present in clinic for a follow up clinical interview, neurologic exam, and CT scan at 2 and 6 weeks post-procedure. This follow up care including the CT scans is considered standard of care for patients undergoing surgery for chronic SDH and it will not expose them to any additional tests or imaging studies.
MMA embolization is done under moderate sedation or general anesthesia using biplane fluoroscopy. Briefly, common femoral artery access is obtained, and a guide catheter is advanced into the external carotid artery. A microcatheter is then advanced into the internal maxillary artery and then the MMA. Particles are then injected. A post-procedure carotid angiography is performed to ensure no reflux of particles into the internal carotid artery circulation. The guide catheter is then removed and femoral hemostasis is obtained. Subjects recover from anesthesia and are observed overnight, undergo a non-contrast head CT the next day, and discharged if appropriate.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Middle Meningeal Artery Embolization
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Middel Meningeal Artery Embolization
Other Intervention Name(s)
MMA
Intervention Description
Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.
Primary Outcome Measure Information:
Title
Changes in neurological status after embolization of the MMA for symptomatic, chronic, and medically refractory SDH.
Description
A neurological exam will be performed to assess any neurological changes post-procedure.
Time Frame
The neurological exam will be performed before the procedure, the day after the procedure, and at 2 and 6 weeks post-procedure to assess any changes in neurological status.
Title
Changes in size of the SDH post-procedure.
Description
A CT scan will be performed to assess the size of the SDH before and after the procedure.
Time Frame
A head CT will be performed to assess the size of the SDH post-procedure. This will occur before the procedure, the day after the procedure, and at 2 and 6 weeks post-procedure.
Secondary Outcome Measure Information:
Title
The safety of embolization of the MMA for symptomatic, chronic, and medically refractory SDH
Description
A neurologic exam will be performed to assess any neurological deficits and/or improvements post-procedure.
Time Frame
Pre-procedure, 1 day post-procedure, and 2 and 6 weeks post-procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age must be greater or equal to 18 years of age.
Subjects must have a diagnosis of chronic or acute-on-chronic subdural hematoma based on brain imaging, as documented by an independent radiologist.
One or more symptoms attributable to chronic SDH including headache, cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
In the opinion of the site investigator or the subject's referring physician, the subject has failed conservative management.
Exclusion Criteria:
The subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment.
Any requirement for urgent surgical evacuation is necessary.
Life expectancy is less than 6 months in the opinion of the subject's primary physician.
Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram.
Acute subdural hematomas.
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jared Knopman, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data for primary and secondary outcome measures will be available.
IPD Sharing Time Frame
Data will be available within one year of study completion
IPD Sharing Access Criteria
Data access requests will be reviewed by the PI.
Learn more about this trial
Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
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