Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

Inclusion Criteria

• •Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neuroendovascular treating team
• •Wide neck side wall or bifurcation intracranial aneurysms (neck \> or = to 4 mm or dome-to-neck ratio \< 2) within the anterior or posterior circulation
• •The neurointerventionist feels that the aneurysm can be safely treated using endovascular techniques (direct or assisted coiling)
• •Patients are 18-80 years of age (inclusive)
• •Patient must be Hunt and Hess grade 0 to 3
• •Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney.
• •Aneurysm 6-14 mm in diameter
• •Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography) at 3-6 months and 12-18 months after endovascular treatment
• •The patient has not been previously enrolled in this trial or another related ongoing trial
• •The aneurysm has not been previously treated by coiling or clipping
• •Target aneurysm has had previous coil treatment or has been surgically clipped
• •Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage
• •Inability to obtain informed consent
• •Medical or surgical comorbidity such that the patient's life expectancy is less than 2 years