New coil system aims to safely block dangerous brain vessels
NCT ID NCT07687472
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This trial tests a new platinum coil system (i-ED Coil and EDG v4) used to block abnormal blood vessels in the brain, called arteriovenous malformations (AVMs). The study includes 36 adults aged 18 to 79 who need this procedure. Researchers will check how well the coils block the vessels and how safely they detach during treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- i-ED Coil and Electro Detach Generator v4 (EDG v4) – a platinum coil system used to block abnormal blood vessels
- What this could lead to
- If successful, this coil system could offer a safer, more reliable way to treat arteriovenous malformations (AVMs) and reduce the risk of bleeding in the brain.
- What could go wrong
- This is a small, post-market study with only 36 participants, so results may not apply to everyone. The procedure itself carries risks like bleeding, stroke, or incomplete blockage of the AVM.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2033
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.