Arteriovenous Malformation (AVM)NCT07687472
Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation
A study testing Endovascular Coil Embolization in people with Arteriovenous Malformation (AVM), run by Kaneka Corporation.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Arteriovenous Malformation (AVM)
- What is being tested?
- Endovascular Coil Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
- Conditions
- Arteriovenous Malformation (AVM)
- Being tested
- Endovascular Coil Embolization
- 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
- Medical subject headings
- Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Coil EmbolizationDevice
Also called i-ED Coil, EDG v4
Endovascular embolization performed using the i-ED Coil, a detachable platinum coil system, in combination with the Electro Detach Generator v4 (EDG v4).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Endovascular Coil Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-procedural AVM Occlusion Assessed by Angiography or MRI
Complete or partial obliteration of AVMs assessed by angiography or MRI.
Measured: 12, 36, 60 months
Successful Coil Embolization Assessed by Angiography
Reduced blood flow to target vessels following coil embolization, assessed by angiography.
Measured: 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.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2033 (estimated)
- Study completion30 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Malformation (AVM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaneka Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687472
- Sponsor's protocol ID
- IED-001
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of i-ED Coil and EDG v4 for Arteriovenous Malformation - A Prospective Study
- ClinicalTrials.gov ID
- NCT07687472
- Acronym / sponsor ID
- IED-001
- Conditions
- Arteriovenous Malformation (AVM)
- Keywords
- Arteriovenous Malformation, AVM, Endovascular Embolization, Coil Embolization, Detachable Coil, i-ED Coil, Electro Detach Generator v4, EDG v4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kaneka CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2033 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| i-ED Coil / Electro-detach Generator v4 | Experimental | Device: Endovascular Coil EmbolizationParticipants 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Coil EmbolizationAlso: i-ED Coil, EDG v4Endovascular embolization performed using the i-ED Coil, a detachable platinum coil system, in combination with the Electro Detach Generator v4 (EDG v4). | Device | i-ED Coil / Electro-detach Generator v4 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Coil Embolization in people with Arteriovenous Malformation (AVM), run by Kaneka Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-procedural AVM Occlusion Assessed by Angiography or MRI (time frame: 12, 36, 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.