Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center

Ohio State University100 enrolled

Overview

The purpose of this study is to evaluate the function of matched pair Aristotle 14 Guidewire and Plato Microcatheter in MMA embolization treatment for chronic subdural hematoma compared to surgeon's preference

If you agree to take part, you will have a 50/50 chance of being assigned to one of two groups. In group 1, your procedure will use the study devices. In group 2, your procedure will use devices chosen by your surgeon. The procedure and follow up are part of standard medical care. This means that taking part in the study will not mean more time or energy compared to the usual treatment you would have.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Chronic Subdural Hematoma Hemorrhage Brain

Interventions

Matched pair Aristotle 14 guidewire and Plato 17 microcatheterDEVICE

Participants will be randomized in 1:1 ratio to either use of study devices (matched pair Aristotle and Plato) or standard of care (surgeon combination preference) using block randomization method with a fixed block size of 4 ensuring 50% will be randomized to study devices group and 50% randomized to standard of care group.

Surgeon combination preferenceDEVICE

Surgeon will decide the on guidewire and microcatheter to use for MMA embolization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years old * Patient or legally authorized representative (LAR) signs an informed consent form * Confirmed diagnosis of subacute or chronic subdural hematoma, defined as 50% or more chronic blood * Pre-morbid Modified Rankin Score of ≤ 3 Exclusion Criteria: * Age \< 18 years old * Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization * Unmanaged, uncontrolled bleeding disorders/blood diathesis * Presumed septic embolus, or suspicion of microbial superinfection * Contraindication to angiography * CT or MRI evidence of intra-cranial tumor or mass lesion

Locations (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Total Navigation/procedure time

Comparing between devices on both navigation and procedure time

Time frame: 2 years

Final Embolization Grades

Comparison between device groups for final embolization grades

Time frame: 2 Years

Incidence of AE at time of surgery

Incidence of device related adverse events and incidence of procedure related adverse events

Time frame: 2 Years

Incidence of recurrence of hemorrhage

Incidence of hematoma reoccurrence/progression requiring re-intervention at 90 day follow-up

Time frame: 2 Years

Central Contacts

Edouard Belizaire

CONTACT

614.366.6936 edouard.belizaire@osumc.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.