CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 342 enrolled
Drug / intervention
MMA embolizationprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04372147
NCT04372147N/ACompleted

Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients, a Randomized Controlled Trial

Assistance Publique - Hôpitaux de Paris·interventional·Posted May 1, 2020·Updated Sep 23, 2024

In Brief

A clinical study evaluating MMA embolization for Chronic Subdural Hematoma and 2 related conditions. Completed, enrolled 342 participants across 12 sites.

Detailed Summary

Standard of care for the management of symptomatic chronic subdural hematomas (SDHs) is neurosurgical burr-hole evacuation followed by drainage. Post-operative recurrence rates may be as high as 10 to 20 %. In particular, recurrence rate increases with antiplatelet and anticoagulant therapy. Middle meningeal artery (MMA) embolization has been proposed as a novel treatment of chronic SDH. The aim of this study is to assess the efficacy of MMA embolization in reducing the risk of chronic SDH recurrence at 6 months after burr-hole surgery as compared with standard medical post-operative treatment in patients at high risk of post-operative recurrence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 1, 2020
Enrollment StartJun 22, 2020
Primary CompletionOct 23, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.2 years ago

Interventions

MMA embolizationprocedure

Patients in the intervention group will undergo a CT angiography scan of the supra aortic trunks, followed by MMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care