i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study

Kaneka Medical America LLC

Summary

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Pre morbid mRS 0-3 * Chronic subdural symptomatic, requiring intervention Exclusion Criteria: * Acute subdural hematoma * Intercranial mass other than subdural hematoma * Females pregnant or breast feeding * Compromised survival or inability to complete trial

Interventions

Device
Neuro endovascular embolic coil
i-ED COIL, Kaneka Corporation

Locations (2)

Westchester Medical Center
Valhalla, New York
fawaz.al-mufti@wmchealth.org 914-493-5098
University of Pennslyvania
Philadelphia, Pennsylvania
jan.burkhardt@pennmedicine.upenn.edu 917-597-9435