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

Not Applicable

Completed

Conditions: Wide-neck, Saccular Intracranial Aneurysms

Interventions: Device: Stent assisted coiling with the Liberty Stent

Registration Number: NCT01636453

Lead Sponsor: Penumbra Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liberty Stent arm	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

Primary Outcome Measures

Name	Time	Method
Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.	At 12 months post-implant
Number of Participants With Raymond Class I Complete Obliteration at 12 Months	At 12 months post-implant	Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).

Secondary Outcome Measures

Name	Time	Method
Number of Ipsilateral Ischemic Strokes	At 12 months post-implant	Defined as episodes of focal or global neurological dysfunction due to brain or retinal infarction in the same hemisphere of the target aneurysm with signs and symptoms that persist for 24 hours or longer. When appropriate, non contrast CT scans will be used to eliminate hemorrhagic strokes
Number of Participants With Device-related Serious Adverse Events	During the procedure	The number of participants with device-related Serious Adverse Events as a measure of safety of the procedure and device. The FDA definitions for Serious Adverse Events are used.
Number of Participants With Aneurysm Raymond Class I Occlusion Grading	At 12 months post-implant	Raymond Class I Occlusion grading defined as complete obliteration of the aneurysm at 12 months.
Number of Intracranial Hemorrhages	At 12 months post-implant	Inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhages (symptomatic or asymptomatic). Symptomatic is defined as a 4 point or more increase in the National Institutes of Health Stroke Scale (NIHSS) from baseline. The NIHSS ranges from 1 to 42, with higher scores indicating greater severity of stroke.
Number of Participants Who Experienced Aneurysm Recanalization	At 12 months post-implant
Number of Device Deployment Failures	During the procedure	Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm
Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2	At 12 months post-implant	The Modified Rankin Scale measures functional ability on a scale from 0-5, with 0 indicating no symptoms at all and 5 indicating severe disability.
Number of Participants Who Experienced Device Patency	at 12 months post-implant	Device patency (stenosis) at 12 months
Number of Device Migrations	12 months post-implant	Migration is defined as movement of the Liberty stent by more than 5 mm as documented by the 12 month angiogram when compared to its immediate post-implant position.
All Cause Mortality (Number of Deaths From Any Cause)	At 12 months post-implant
Number of Retreatments	At 12 months post-implant	Defined as any intervention after the completion of the initial stent assisted coiling procedure

Trial Locations

Locations (3): Stony Brook University Medical Center
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Stony Brook, New York, United States
Swedish Medical Center
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Denver, Colorado, United States
Rush University Medical Center
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Chicago, Illinois, United States