Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization
NCT ID: NCT05374681
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
550 participants
INTERVENTIONAL
2023-03-28
2028-09-28
Brief Summary
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Preliminary case series and nonrandomized retrospective studies have suggested that MMA embolization alone or as adjuvant therapy to surgery can decrease recurrences.
The investigators hypothesize that in both conditions of conservative or surgical managements, endovascular embolization of patients with CSH significantly reduces the risk of recurrence of CSH. The investigators choose the CYA as liquid embolic agent because of the pain and cost of the use of Ethylen Vinyl alcohol copolymer (EVOH) agents and its simplicity to be used.
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Detailed Description
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* Experimental arm:
CSH requiring hematoma removal will be surgically managed with a surgical technique applied depending on the surgeon's discretion.
Medical management will be adopted according to neurosurgeons habits. MMA embolization (on the CSH side or bilaterally if necessary) in the Experimental Arms will be performed with Cyanoacrylates and preferentially using conscious sedation or local anesthesia.
• Control arm: CSH requiring hematoma removal will be surgically managed with a surgical technique applied depending on the surgeon's discretion.
Medical management will be adopted according to neurosurgeons habits
• Primary and secondary end points will be assessed at 2 months+/- 1 month and assessed at 6 +/- 2 months. The blind items will be the mRS and the RACE score. The volume of the CSH will be semi-automatically assessed using the ABC/2 method and the estimated maximal thickness of the CSH on axial images.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Medical treatment alone
Medical treatment without embolization of the MMA.
Medical treatment
Medical treatment alone
Surgical treatment alone
Surgical treatment without embolization of the MMA.
Surgical treatment
Surgical treatment alone
Medical treatment associated with an embolization of the MMA
Medical treatment + embolization under local anesthesia or conscious sedation. The embolization will be carried out by femoral or radial arterial guided by pre-embolization cervical CTA. The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Medical treatment
Medical treatment alone
embolization of the MMA
The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Surgical treatment associated with an embolization of the MMA
Surgical treatment + embolization under local anesthesia or conscious sedation. The embolization will be carried out by femoral or radial arterial guided by pre-embolization cervical CTA. The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Surgical treatment
Surgical treatment alone
embolization of the MMA
The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Interventions
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Medical treatment
Medical treatment alone
Surgical treatment
Surgical treatment alone
embolization of the MMA
The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Eligibility Criteria
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Inclusion Criteria
* CSH localized to convexity
* Patient aged 18 years or more at the time of the enrollment
* Patient beneficiary from health insurance
Exclusion Criteria
* Pre-existing severe disability resulting in baseline mRS score \> 3
* Life expectancy of less than 6 months due to another cause than CSH
* Patient under legal protection or deprived of liberty by a judicial or administrative decision
* Pregnant or breastfeeding women
* Vulnerable persons unable to give consent
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHU Amiens-Picardie
Amiens, France, France
CHU Brest
Brest, France, France
CHU Caen
Caen, France, France
Hôpital Henri Mondor
Créteil, France, France
CHU Nantes
Nantes, France, France
CHU Nice
Nice, France, France
Hôpital Pitié Salpêtrière
Paris, France, France
Hôpital Fondation Rothschild
Paris, France, France
CHU Tours
Tours, France, France
CHU Bordeaux
Bordeaux, , France
CHU Nancy
Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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29BRC22.0028
Identifier Type: -
Identifier Source: org_study_id
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