Chronic Subdural HematomaNCT03307395
Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
A study testing Middel Meningeal Artery Embolization in people with Chronic Subdural Hematoma, run by Weill Medical College of Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Middel Meningeal Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2017to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Middel Meningeal Artery Embolization
- Keywords
- Chronic Subdural Hematoma, Embolization, Middle meningeal artery
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middel Meningeal Artery EmbolizationProcedure or surgery
Also called MMA
Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.
| Study group | Role | What they receive |
|---|---|---|
| Middle Meningeal Artery Embolization | Experimental | Not described Receives: Procedure: Middel Meningeal Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
A neurologic exam will be performed to assess any neurological deficits and/or improvements post-procedure.
Measured: Pre-procedure, 1 day post-procedure, and 2 and 6 weeks post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start31 Oct 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jared Knopman, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307395
- Sponsor's protocol ID
- 1611017746
- Status last verified
- Feb 2020
- First submitted
- 28 Sep 2017
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data for primary and secondary outcome measures will be available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT03307395
- Acronym / sponsor ID
- 1611017746
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic Subdural Hematoma, Embolization, Middle meningeal artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle Meningeal Artery Embolization | Experimental | Procedure: Middel Meningeal Artery Embolization |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Middel Meningeal Artery EmbolizationAlso: MMABlood supply to the subdural hematoma via the middle meningeal artery is interrupted. | Procedure or surgery | Middle Meningeal Artery Embolization |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: Yes. De-identified participant data for primary and secondary outcome measures will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Knopman, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Middel Meningeal Artery Embolization in people with Chronic Subdural Hematoma, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.