Health TrialsbyHealthPanel

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

ConditionsChronic Subdural HematomaHemorrhage Brain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients admitted to The Ohio State University Wexner Medical Center

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Matched pair Aristotle 14 guidewire and Plato 17 microcatheter

    Device

    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 preference

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Total Navigation/procedure time

Comparing between devices on both navigation and procedure time

Time frame
2 years
2

Final Embolization Grades

Comparison between device groups for final embolization grades

Time frame
2 Years
3

Incidence of AE at time of surgery

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

Time frame
2 Years
4

Incidence of recurrence of hemorrhage

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

Time frame
2 Years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Scientia Vascular, Inc.

Collaborator

Source ClinicalTrials.gov
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