An interventional study of Middel Meningeal Artery Embolization in Chronic Subdural Hematoma, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-03-04.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
Among 21 studies in Hematoma, Subdural, Chronic with a site in United States — 9 open to participants now, 9 under way, none of them phase 3. Hematoma, Subdural, Chronic · United States.
Among the 21 studies in Hematoma, Subdural, Chronic with a site in United States, this one is the 11th largest by enrollment of the 14 interventional ones that give a count, is the only one that started in 2017, is one of 10 with no phase, and was the 2nd registered.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
Browse Hematoma, Subdural, Chronic studies →9 of the 21 studies in Hematoma, Subdural, Chronic with a site in United States are open now. Recruiting first, the newest first:
Arsenal Medical, Inc. · Sites in United States
Ages 18–90
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 18+
Ohio State University · Sites in United States
Ages 18+
Lahey Clinic · Sites in United States
Ages 18+
The University of Texas Medical Branch, Galveston · Sites in United States
Ages 40–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 35 Hematoma, Subdural, Chronic studies recruiting now, 26 (74%) set no upper age limit and 1 (3%) stops at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Median enrollment 35 across the 14 interventional studies, 100 across the 7 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.
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4 of 21 have an industry lead sponsor. The 10 most frequent:
Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Weill Medical College of Cornell University has 1 study filed under Hematoma, Subdural, Chronic — fewer than ten, so there is no comparison to draw.
4 of the studies in Hematoma, Subdural, Chronic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07214623Kaneka Medical America LLCProspective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy | 2026-11-30 |
| NCT06181994Montefiore Medical CenterMiddle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH) | 2026-12 |
| NCT07715656Lahey ClinicAssessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas | 2027-04-30 |
| NCT07757113Sanford HealthComparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization | 2027-09 |
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Among the 21 studies in Hematoma, Subdural, Chronic with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Middel Meningeal Artery Embolization
Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.
Also known as: MMA
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.
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.
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.
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.
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.
Time frame: Pre-procedure, 1 day post-procedure, and 2 and 6 weeks post-procedure.
Plan to share: Yes — De-identified participant data for primary and secondary outcome measures will be available.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will be available within one year of study completion
Access criteria: Data access requests will be reviewed by the PI.
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Jul 2018, 8 months.
Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University →