An interventional study of embolization of the middle meningeal artery in Subdural Hematoma, Chronic, sponsored by Ospedale Policlinico San Martino. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by Ospedale Policlinico San Martino · Not applicable, Interventional, and Treatment
Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1.
Patients randomized to the experimental arm will submit to cerebral angiography and bilateral MMA embolization of the cSHD, even if it is located to only one side. The ipsilateral MMA embolization of the cSDH is allowed when the endovascular procedure cannot be performed on both sides. Patients are preferably under monitored local anesthesia or alternatively under conscious sedation or general anesthesia. Briefly, through femoral or radial artery access a standard 5 French diagnostic catheter is placed in the proximal external carotid artery and a digital subtraction angiography (DSA) is performed. Then, a microcatheter is advanced selectively under roadmap guidance into the main trunk of MMA, and superselective angiography is performed to evaluate for potentially dangerous anastomoses between MMA and ophthalmic or petrous branches prior to embolization. After collateral vessels are excluded, the MMA is occluded with PVA particles or liquid embolizing materials . The successful embolization is defined as that both frontal and parietal branch of MMA are selectively occluded and for this purpose, the microcatheter should be placed as distally as possible. It is recommended to ensure embolic materials penetrating into the capillary network of the dura to be permanently blocked. Patients randomized to the conservative arm will be clinmically monitored and eventually receive a best supportive care according to the local practice.
The trial is powered to assess superiority. When assuming the event rate of 1% in intervention group and 10% event rate in the control group, with a power of 85% and two-sided alpha of 0.05, allowing for 10% drop-outs, the estimated sample size is 300 patients in total.
The safety and efficacy interim analysis will be planned when half of the target sample (150 patients) completed 6 months follow-up. The enrollment will be stopped if the futility assessment based on estimated conditional power will be \<70%.
All patient data is registered in the electronic data capture software REDCap. This worldwide online system allows built-in logical checks and validations to promote data quality. All clinical data are entered via an encrypted connection, are anonymized, and fulfill the demands for data protection. All data entries and changes are logged in REDCap and meet the Good Clinical Practice (GCP) requirements for the use of the electronic case report form (eCRF) in medical trials. Trial coordinators, data managers and the investigators will be introduced to the platform and trained in data entry during the initial kick-of meeting prior to recruitment of the first patient. Trial staff will be provided with a personal ID.
Currently, 6 centers in Italy have been identified for the study. All the clinical investigators are board-certified and have renowned expertise in neurosurgery, neuroradiology and endovascular interventions.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 300 is above the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Ospedale Policlinico San Martino is the lead sponsor of 30 studies on the registry; 11 are open to participants now.
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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.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Life expectancy
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Endovascular treatment of chronic subdural hematoma
Device: embolization of the middle meningeal artery
control group will managed according to the current standard of care with "wait and see" approach and best medical treatment
Embolization of the MMA is occluded with PVA particles or liquid embolizing materials
Rate of incomplete hematoma resolution or surgical rescue
Incomplete hematoma resolution is defined as a reduction of the cSDH thickness ≤50% at follow-up compared to the hematoma thickness measured at the time of randomization. Surgical rescue is intended as hematoma removal for relief of symptoms (mRS≥3 and Markwalder scale≥2) that develope with progressive growth of the cSDH
Time frame: 6 months
treatment complication
Procedure related complication during or 30 days after MMA embolization
Time frame: 30 days
treatment successful
Successful embolization rate of the target vessels based on angiographic findings
Time frame: periprocedural
No study locations are listed for this record.
Plan to share: No
Start is estimated for Mar 2024; primary completion for Mar 2025, 12 months later.
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 planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Ospedale Policlinico San Martino