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

Penumbra

Status: Completed

Conditions: Wide-neck, Saccular Intracranial Aneurysms

Treatments: Device: Stent assisted coiling with the Liberty Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01636453

CLP 5038 (IDE # G120050)

Details and patient eligibility

About

To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. The implant component is made of superelastic and biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved embolic coils currently on the market. Wide-neck aneurysms are defined by a neck ≥4mm or a dome-to-neck ratio <2. Each patient will be followed and assessed for 2, 6 and 12 months after enrollment.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Liberty Stent arm

Experimental group

Description:

Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months

Treatment:

Device: Stent assisted coiling with the Liberty Stent