Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)

Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS

The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.

Inclusion Criteria:

• Subject age between 18 and 75 years
• Subject with an unruptured or ruptured(>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio <2)intracranial saccular aneurysm (<20mm maximum diameter in any plane)

Exclusion Criteria:

• Subject with significant extra or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.
• Subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke
• Subject with contraindications to the use of antiplatelet agents
• Subject who is unable to complete the required follow-up