The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms

Inclusion Criteria:

- At least 18 years old

- A wide-neck intracranial saccular aneurysm with a neck ≥ 4mm or a dome to neck ratio
<2 in the ICA from the cavernous segment to the carotid terminus (including the
paraclinoid, ophthalmic, hypophyseal and posterior communicating segments)

- Life expectancy > 12 months

- Signed Informed Consent

Exclusion Criteria:

- Females who are pregnant or intend to become pregnant during the study. (Females of
child-bearing potential must have a urinary pregnancy test within 7 days of
enrollment)

- Extradural aneurysms

- Known multiple untreated cerebral aneurysms at study entry

- Recent history of subarachnoid hemorrhage, intracranial hemorrhage, or major surgery
within one month of enrollment

- Admission platelet <50,000 or any known hemorrhagic diathesis, coagulation deficiency,
or on oral anticoagulant therapy with an INR >3.0

- Contraindication to angiography such as elevated creatinine or known allergy to
angiographic contrast

- Contraindication to CT and/or MRI scans

- Known allergy to the metal component of the Penumbra Liberty Stent System

- Evidence of active infection (WBC >10x109 /L)

- Any medical conditions that will not allow the necessary follow-up for this study
(e.g., pre-existing neurological or psychiatric diseases)

- Current substance-abuse /illicit drug use

- Angiographic evidence of an arterial stenosis proximal to the target lesion that could
prevent device deployment

- Contraindications to study medications (heparin, aspirin, clopidogrel, and
radiographic contrasts)