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Kaneka Endovascular Embolization and Protection | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Kaneka Endovascular Embolization and Protection

NCT05563051•Kaneka Medical America LLC

Summary

Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure

Detailed Description

Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s) Study Duration Anticipated timeline for study: Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Target aneurysm of 4mm - 14mm in size
•Ruptured or unruptured
•Suitable for embolization with coils
•May be treated with or without assist devices

Exclusion Criteria

•Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)
•Pre-planned staged procedure of target aneurysm
•mRS score 3 or more
•Hunt Hess Score more than 3 for subjects with ruptured aneurysm
•Evidence of active infection (e.g.,fever, temperature \>38 degrees C and/or WBC \>15,000)

Locations (4)

McLaren Health Care

Grand Blanc, Michigan, United States

Northwell Health Lenox Hill Hospital

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

SSM Health St. Anthony's Hospital

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

December 13, 2022

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

October 7, 2025

Enrollment

164

ESTIMATED participants

Conditions

Aneurysm Cerebral

Interventions

i-ED COIL

DEVICE

Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices

NCT06215105

Aneurysm Cerebral

View study

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 7, 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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