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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

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

NCT07214623•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

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

November 30, 2025

Primary Completion Date

November 30, 2026

Completion Date

May 31, 2027

Last Updated

October 9, 2025

Enrollment

200

ESTIMATED participants

Conditions

Chronic Subdural HematomacSDHChronic Subdural Hematomas

Interventions

Neuro endovascular embolic coil

DEVICE

Contacts

Yuki Arimoto

CONTACT

212-705-4340 yuki.arimoto@kaneka.com

Leah Lyons, PA

CONTACT

212-705-4340 leah.lyons@kaneka.com

Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization

Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center

Registry of Chronic Subdural Hematoma

Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma

Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)