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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorKaneka Corporation

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

Treatment groups

36 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators