Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation

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).

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Key information

Conditions

Arteriovenous Malformation (AVM) Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Vascular Diseases Vascular Malformations

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects aged 18 to <80 years
Subjects requiring endovascular treatment using coils for arteriovenous malformation
Free and informed consent to participate in the investigation obtained from the subject or an acceptable subject representative

Exclusion criteria

Coiling or stenting performed on the non-target lesion within 30 days prior to treatment of the target lesion
Hunt and Hess score of 3 or higher or modified Rankin Score (mRS) of 4 or higher
Subjects with contraindications to CT or MRI procedures
Subjects with contraindications to angiography procedures
Pregnant or breastfeeding subjects

Treatment and study plan

Endovascular Coil Embolization

Device

Endovascular embolization performed using the i-ED Coil, a detachable platinum coil system, in combination with the Electro Detach Generator v4 (EDG v4).

Other names: i-ED Coil, EDG v4

Primary outcomes

Post-procedural AVM Occlusion Assessed by Angiography or MRI

Time frame: 12, 36, 60 months

Complete or partial obliteration of AVMs assessed by angiography or MRI.
Successful Coil Embolization Assessed by Angiography

Time frame: 12, 36, 60 months

Reduced blood flow to target vessels following coil embolization, assessed by angiography.
The Frequency of Detachment of Coils During Treatment Procedure

Time frame: Periprocedural

Frequency of successful coil detachment using the EDG v4 during the treatment procedure.

Sponsors and collaborators

Lead sponsor

Kaneka Corporation

Industry

Registry information

Official study title

Safety and Efficacy of i-ED Coil and EDG v4 for Arteriovenous Malformation - A Prospective Study

Important dates

Study start: 2026
Primary completion: 2033
Study completion: 2033
First posted: Jul 7, 2026
Registry last updated: Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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