About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Endovascular Coil Embolization