Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma

Chronic Subdural Hematoma Clinical Trial

Official title:

Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307395
• Other study ID #: 1611017746
• Status: Completed
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: February 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• Middel Meningeal Artery Embolization
Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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	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.	Pre-procedure, 1 day post-procedure, and 2 and 6 weeks post-procedure.