Overview
Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure
Description
Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s)
Study Duration
Anticipated timeline for study:
Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled
Eligibility
Inclusion Criteria:
- Target aneurysm of 4mm - 14mm in size
- Ruptured or unruptured
- Suitable for embolization with coils
- May be treated with or without assist devices
Exclusion Criteria:
- Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)
- Pre-planned staged procedure of target aneurysm
- mRS score 3 or more
- Hunt Hess Score more than 3 for subjects with ruptured aneurysm
- Evidence of active infection (e.g.,fever, temperature >38 degrees C and/or WBC >15,000)
