Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation (NCT07687472) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation
36 participantsStarted 2026-10-01
Plain-language 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).
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-procedural AVM Occlusion Assessed by Angiography or MRI
Timeframe: 12, 36, 60 months
2
Successful Coil Embolization Assessed by Angiography
Timeframe: 12, 36, 60 months
3
The Frequency of Detachment of Coils During Treatment Procedure