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

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.

Study Overview

• Status: Completed
• Conditions: Wide-neck, Saccular Intracranial Aneurysms
• Intervention / Treatment: Device: Stent assisted coiling with the Liberty Stent

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80112
      • Swedish Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • New York
    • Stony Brook, New York, United States, 11794-8122
      • Stony Brook University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Ipsilateral Ischemic Strokes	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	At 12 months post-implant
Number of Participants With Device-related Serious Adverse Events	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.	During the procedure
Number of Device Deployment Failures	Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm	During the procedure
Number of Device Migrations	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.	12 months post-implant
Number of Participants With Aneurysm Raymond Class I Occlusion Grading	Raymond Class I Occlusion grading defined as complete obliteration of the aneurysm at 12 months.	At 12 months post-implant
Number of Intracranial Hemorrhages	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.	At 12 months post-implant
Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2	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.	At 12 months post-implant
All Cause Mortality (Number of Deaths From Any Cause)		At 12 months post-implant
Number of Retreatments	Defined as any intervention after the completion of the initial stent assisted coiling procedure	At 12 months post-implant
Number of Participants Who Experienced Device Patency	Device patency (stenosis) at 12 months	at 12 months post-implant
Number of Participants Who Experienced Aneurysm Recanalization		At 12 months post-implant

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Demtrius Lopes, MD, Rush University Medical Center; Principal Investigator: Henry Woo, MD, Stony Brook University Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: July 2, 2012
• First Submitted That Met QC Criteria: July 5, 2012
• First Posted (ESTIMATE): July 10, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2018
• Last Update Submitted That Met QC Criteria: July 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Stent assisted coiling; intracranial aneurysms; wide-neck; saccular; ICA; Liberty Stent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CLP 5038 (IDE # G120050)