Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Arteriovenous MalformationAVMEndovascular EmbolizationCoil EmbolizationDetachable Coili-ED CoilElectro Detach Generator v4EDG v4Post-Market Clinical Follow-upPMCF

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 EmbolizationDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects aged 18 to \<80 years
Subjects requiring endovascular treatment using coils for arteriovenous malformation

Sponsors & Collaborators

Kaneka Corporation
Industrylead

MeSH Terms

Conditions

Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Vascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, 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

October 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

September 30, 2033

Estimated

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

i-ED Coil / Electro-detach Generator v4

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

i-ED Coil / Electro-detach Generator v4

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record