NCT05636124View on ClinicalTrials.gov

Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

NAActive, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 2, 2023

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2027

Conditions
Intracranial AneurysmsWide Neck Intracranial Aneurysms
Interventions
DEVICE

Kaneka i-ED coil

The study device is the Kaneka i-ED coil T, FDA cleared under 510K number K192068. The coil is indicated for use in the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Trial Locations (5)

10029

Icahn School of Medicine at Mount Sinai, New York

29605

Prisma Health, Greenville

32207

Baptist Health Jacksonville, Jacksonville

33606

University of South Florida, Tampa

94526

Sutter Health, Danville

Sponsors

Collaborators (1)

Kaneka Corporation
All Listed Sponsors
collaborator

Kaneka Corporation

INDUSTRY

lead

Icahn School of Medicine at Mount Sinai

OTHER