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Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
Sponsor: Icahn School of Medicine at Mount Sinai
Summary
This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.
Official title: Cost Effectiveness, Safety, and Efficacy of the Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-06-02
Completion Date
2027-07
Last Updated
2025-07-09
Healthy Volunteers
No
Interventions
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.
Locations (5)
Sutter Health
Danville, California, United States
Baptist Health Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Prisma Health
Greenville, South Carolina, United States