Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
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|ClinicalTrials.gov Identifier: NCT03307395|
Recruitment Status : Enrolling by invitation
First Posted : October 11, 2017
Last Update Posted : March 2, 2020
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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.
- 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.
- 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.
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
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Jared Knopman, MD||Weill Medical College of Cornell University|