Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation
NCT07687472 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-07-07
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).
Conditions
- Arteriovenous Malformation (AVM)
Interventions
- DEVICE
-
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).
Sponsors & Collaborators
-
Kaneka Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-01
- Primary Completion
- 2033-09-30
- Completion
- 2033-09-30
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