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

NCT07687472 | Not Yet Recruiting DMC

• 1 other identifier: IED-001
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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).

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

Outcome Measures

Primary Outcomes (3)

• Post-procedural AVM Occlusion Assessed by Angiography or MRI

  Complete or partial obliteration of AVMs assessed by angiography or MRI.

  12, 36, 60 months

• Successful Coil Embolization Assessed by Angiography

  Reduced blood flow to target vessels following coil embolization, assessed by angiography.

  12, 36, 60 months

• The Frequency of Detachment of Coils During Treatment Procedure

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

  Periprocedural

Study Arms (1)

i-ED Coil / Electro-detach Generator v4

EXPERIMENTAL

Participants with arteriovenous malformations (AVMs) will undergo endovascular coil embolization using the i-ED Coil in combination with the Electro Detach Generator v4 (EDG v4). The study will collect safety and performance data during follow-up.

Device: Endovascular Coil Embolization

Interventions

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).

Also known as: i-ED Coil, EDG v4

i-ED Coil / Electro-detach Generator v4

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaneka Corporation: lead

MeSH Terms

Conditions

Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2033
• Study Completion (Estimated): September 30, 2033
• Last Updated: July 7, 2026

Record last verified: 2026-07