Kaneka Endovascular Embolization and Protection

Kaneka Endovascular Embolization and Protection

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

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

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)