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

July 1, 2026 updated by: Kaneka Corporation

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: i-ED Coil / Electro-detach Generator v4
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12, 36, 60 months
Successful Coil Embolization Assessed by Angiography
Time Frame: 12, 36, 60 months
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
Time Frame: Periprocedural
Frequency of successful coil detachment using the EDG v4 during the treatment procedure.
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaneka Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2033

Study Completion (Estimated)

September 30, 2033

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IED-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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