Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03307395
Recruitment Status : Enrolling by invitation
First Posted : October 11, 2017
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Procedure: Middel Meningeal Artery Embolization Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Middle Meningeal Artery Embolization Procedure: Middel Meningeal Artery Embolization
Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.
Other Name: MMA


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes in neurological status after embolization of the MMA for symptomatic, chronic, and medically refractory SDH. [ 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. ]
    A neurological exam will be performed to assess any neurological changes post-procedure.

  2. Changes in size of the SDH post-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. ]
    A CT scan will be performed to assess the size of the SDH before and after the procedure.


Secondary Outcome Measures :
  1. The safety of embolization of the MMA for symptomatic, chronic, and medically refractory SDH [ Time Frame: Pre-procedure, 1 day post-procedure, and 2 and 6 weeks post-procedure. ]
    A neurologic exam will be performed to assess any neurological deficits and/or improvements post-procedure.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307395


Locations
Layout table for location information
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Jared Knopman, MD Weill Medical College of Cornell University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03307395    
Other Study ID Numbers: 1611017746
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data for primary and secondary outcome measures will be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will be available within one year of study completion
Access Criteria: Data access requests will be reviewed by the PI.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Chronic Subdural Hematoma
Embolization
Middle meningeal artery
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries