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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07687472

Enrollment

Registered

2026-07-07

Start date

2026-10-01

Completion date

2033-09-30

Last updated

2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Malformation (AVM)

Keywords

Arteriovenous Malformation, AVM, Endovascular Embolization, Coil Embolization, Detachable Coil, i-ED Coil, Electro Detach Generator v4, EDG v4, Post-Market Clinical Follow-up, PMCF

Brief 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).

Interventions

DEVICEEndovascular 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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Post-procedural AVM Occlusion Assessed by Angiography or MRI	12, 36, 60 months	Complete or partial obliteration of AVMs assessed by angiography or MRI.
Successful Coil Embolization Assessed by Angiography	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	Periprocedural	Frequency of successful coil detachment using the EDG v4 during the treatment procedure.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026