Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 2/24/2019 |
| Start Date: | October 31, 2017 |
| End Date: | December 31, 2021 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
