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Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma

NCT03307395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-03-04

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Subdural Hematoma

Interventions

PROCEDURE

Middel Meningeal Artery Embolization

Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Jared Knopman, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-07-30
Completion
2018-07-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03307395 on ClinicalTrials.gov