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

NCT ID: NCT01636453

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-12-31

Brief Summary

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.

Conditions

Wide-neck, Saccular Intracranial Aneurysms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liberty Stent arm

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

Group Type: EXPERIMENTAL

Stent assisted coiling with the Liberty Stent

Intervention Type: DEVICE

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

Interventions

Stent assisted coiling with the Liberty Stent

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penumbra Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Demtrius Lopes, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Henry Woo, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University Medical Center

Locations

Swedish Medical Center

Denver, Colorado, United States

Rush University Medical Center

Chicago, Illinois, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Countries

United States

Other Identifiers

CLP 5038 (IDE # G120050)

Identifier Type: -

Identifier Source: org_study_id