Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy

N/ANot Yet RecruitingNCT07214623

Kaneka Medical America LLC200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Chronic Subdural Hematoma cSDH Chronic Subdural Hematomas

Interventions

Neuro endovascular embolic coilDEVICE

i-ED COIL, Kaneka Corporation

Eligibility

Medical Language ↔ Plain English

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

Locations (2)

Westchester Medical Center

Valhalla, New York, United States

University of Pennslyvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Effectiveness

Incidence of hematoma recurrence or progression requiring repeat embolization within 180 days

Time frame: 6 months

Safety

Modified rankin scale at 90 days post procedure

Time frame: 90 days

Data from ClinicalTrials.gov

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