Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163547
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-20
Brief Title:
Middle Meningeal Artery Embolization for Chronic Subdural Hematomas STORMM
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Middle Meningeal Artery MMA Embolization for cSDH Rationale and Design for the STOp Recurrence of MMA Bleeding STORMM Randomized-Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STORMM
Brief Summary:
Chronic Subdural Hematomas cSHD are common and due to cerebral compression often result in neurological impairment and reduced consciousness Surgery is typically performed once neurological symptoms develop Recent studies suggest that arteries nourished by the middle meningeal artery MMA may be responsible for hematoma progression and that MMA embolization is clinically useful There is less evidence that embolization of MMA also may be a treatment option for individuals without surgical treatment The investigators propose a multicentre study to investigate both potentials 1 Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial randomization arms Arms 1 and 2 2 Assessment of embolization-alone efficacy when surgery is contraindicated or refused embolization-only arm Arms 3 and 4
Detailed Description:
Evidence to support the benefit of MMA embolization remains limited and the risk-benefit balance remains unclear Case series have shown that recurrence rates with embolization are much lower and that embolization is generally very safe Risks associated with neurointerventional procedures will be directly discussed with patients or their caretakers as part of the conventional consenting procedure Risks include access site hematoma radiation exposure vascular injury brain ischemia death theoretic and extremely unlikely and typical risks associated with general or local anaesthesia The potential efficacy of MMA embolization as a treatment therefore requires higher level evidence in the form of randomized control trials
The benefit of the embolization is a substantial reduction in recurrence of cSDH which has been reported to be as high 1 in 3-4 patients Recurrence of cSDH can lead to additional surgery and complications
First objective Evaluate the recurrence rates of cSDH after combined surgical and MMA embolization treatments Arm 2 versus surgery alone Arms 1
Second objective The second objective is to evaluate the stability and regression of cSDH after for all the Arms of the study at follow-up
The benefit of the embolization is a substantial reduction in recurrence of cSDH which has been reported to be as high 1 in 3-4 patients Recurrence of cSDH can lead to additional surgery and complications
First objective Evaluate the recurrence rates of cSDH after combined surgical and MMA embolization treatments Arm 2 versus surgery alone Arms 1
Second objective The second objective is to evaluate the stability and regression of cSDH after for all the Arms of the study at follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None