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Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation
Sponsor: Kaneka Corporation
Summary
This is a prospective, multicenter, post-market clinical follow-up (PMCF) study to collect safety and performance data in patients with arteriovenous malformations (AVMs) who undergo endovascular coil embolization using the i-ED Coil and Electro Detach Generator v4 (EDG v4).
Official title: Safety and Efficacy of i-ED Coil and EDG v4 for Arteriovenous Malformation - A Prospective Study
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-10-01
Completion Date
2033-09-30
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Endovascular Coil Embolization
Endovascular embolization performed using the i-ED Coil, a detachable platinum coil system, in combination with the Electro Detach Generator v4 (EDG v4).