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All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuro endovascular embolic coil | Device | i-ED COIL, Kaneka Corporation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | Incidence of hematoma recurrence or progression requiring repeat embolization within 180 days | 6 months |
| Safety | Modified rankin scale at 90 days post procedure | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic subdural hematomas with symptoms
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuki Arimoto | Contact | 212-705-4340 | yuki.arimoto@kaneka.com | |
| Leah Lyons, PA | Contact | 212-705-4340 | leah.lyons@kaneka.com |
| Name | Affiliation | Role |
|---|---|---|
| Fawaz Al-Mufti, MD | Westchester Medical Center | Principal Investigator |
| Jan-Karl Burkhardt, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
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| University of Pennslyvania | Philadelphia | Pennsylvania | 11104 | United States |
|
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| 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 |
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