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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 PHILâ„¢ (investigational arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical management | Active Comparator | Control arm |
|
| PHIL embolic | Experimental | Treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHILâ„¢ (Precipitating Hydrophobic Injectable Liquid) | Device | Embolization of MMA with PHIL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Incidence of mRS 0-2. | 90 days post procedure |
| Primary Effectiveness Endpoint | Incidence of clinically indicated (as adjudicated by CEC) surgical evacuation of the target cSDH among subjects in the PHILâ„¢ MMAE arm. | 90 days post procedure |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Tran | Contact | 949-678-1949 | jennifer.tran@terumo.com | |
| Amy Bowles | Contact | 714-482-8074 | amy.bowles@microvention.com |
| Name | Affiliation | Role |
|---|---|---|
| David Fiorella | Stony Brook University | Principal Investigator |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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Sponsor is blinded
| Surgical evacuation | Procedure | Surgical evacuation of cSDH. |
|
| 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 |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |