Chronic Subdural Hematomas
Conditions
Brief summary
This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to either initial surgical evacuation (Control Arm) or initial MMAE with PHIL™ (investigational arm).
Interventions
DEVICEPHIL™ (Precipitating Hydrophobic Injectable Liquid)
Embolization of MMA with PHIL.
PROCEDURESurgical evacuation
Surgical evacuation of cSDH.
Sponsors
Microvention-Terumo, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Sponsor is blinded
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 22 years or older * Diagnosis of chronic subdural hematoma * Subject, or their legally authorized representative provides a signed and dated Informed Consent Form * Pre-morbid mRS 0-1 * cSDH measures ≥ 10 mm in greatest thickness * cSDH exerts mass effect upon the subjacent brain * Imaging characteristics indicative of chronicity * Negative urine pregnancy test for female subjects of child-bearing potential * Subject is able and willing to comply with all study protocol requirements, including return to the investigational site for all follow-up visits * Subject presents with one or more of the following neurological symptoms: headache/head pressure, cognitive decline, speech difficulty or aphasia, gait impairment or imbalance, focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop), and/or seizure
Exclusion criteria
* Prior ipsilateral craniotomy or burr hole evacuation of cSDH * Prior embolization of either MMA * Requires (in the opinion of the treating surgeon) full or mini-craniotomy at time of randomization * Emergent subdural hematoma evacuation needed * cSDH with a focal location * cSDH developed due to underlying condition * Life expectancy of \<1 year * Presents with an intracranial mass other than subdural hematoma * Presents with a meningioma with mass effect and/or ≥1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region * Serum creatinine level \> 3.0 mg/dL at time of enrollment and not on dialysis * Life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically) * Currently enrolled in another investigational study protocol that could potentially confound the interpretation of the study endpoints/outcomes * Known dangerous anatomic variations leading to increased procedural risk or unsafe access for MMAE * Contraindicated for the use of PHIL™ liquid embolic system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 90 days post procedure | Incidence of mRS 0-2. |
| Primary Effectiveness Endpoint | 90 days post procedure | Incidence of clinically indicated (as adjudicated by CEC) surgical evacuation of the target cSDH among subjects in the PHIL™ MMAE arm. |
Secondary
| Measure | Time frame |
|---|---|
| Death or major disabling stroke. | 30-, 90-, and 180-days post-index procedure |
| The composite of: recurrent or residual chronic subdural hematoma on the target side measuring ≥ 10 mm; retreatment; or major disabling stroke, myocardial infarction, or death from neurologic causes. | 180 days post procedure |
| Resolution of cSDH without retreatment. | 90- and 180-days post procedure |
| Neurological death | 90- and 180-days post procedure |
| Change in EQ-5D-5L from baseline | 90- and 180-days post procedure |
| cSDH-related hospital re-admissions and re-admission days | 90- and 180-days post procedure |
| Index hospitalization length of stay | post procedure |
| Neurological Events of Interest: minor stroke, major stroke, cSDH expansion, acute cSDH, mRS deterioration of 2 points or greater | 90 days and 180 days post procedure |
Contacts
CONTACTJennifer Tran
CONTACTAmy Bowles
PRINCIPAL_INVESTIGATORDavid Fiorella
Stony Brook University
Outcome results
None listed