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ACTIVE NOT RECRUITING
NCT05636124
NA

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

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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

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.

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