Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma

NCT03307395 | Completed DMC

• 1 other identifier: 1611017746
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic Subdural Hematoma; Embolization; Middle meningeal artery

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• The safety of embolization of the MMA for symptomatic, chronic, and medically refractory SDH

  Pre-procedure, 1 day post-procedure, and 2 and 6 weeks post-procedure.

Study Arms (1)

Middle Meningeal Artery Embolization

EXPERIMENTAL

Procedure: Middel Meningeal Artery Embolization

Interventions

Middel Meningeal Artery Embolization PROCEDURE

Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.

Also known as: MMA

Middle Meningeal Artery Embolization

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; 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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Jared Knopman, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 11, 2017
• Study Start: October 31, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: March 4, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available within one year of study completion
• Access Criteria: Data access requests will be reviewed by the PI.

Locations

US (1)