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

Primary Purpose

Wide-neck, Saccular Intracranial Aneurysms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stent assisted coiling with the Liberty Stent
Sponsored by
Penumbra Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wide-neck, Saccular Intracranial Aneurysms focused on measuring wide-neck, saccular, intracranial aneurysms, ICA, Stent assisted coiling, Liberty Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Swedish Medical Center
  • Rush University Medical Center
  • Stony Brook University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liberty Stent arm

Arm 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

Outcomes

Primary Outcome Measures

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).
Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.

Secondary Outcome Measures

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
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.
Number of Device Deployment Failures
Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm
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.
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.
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.
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.
All Cause Mortality (Number of Deaths From Any Cause)
Number of Retreatments
Defined as any intervention after the completion of the initial stent assisted coiling procedure
Number of Participants Who Experienced Device Patency
Device patency (stenosis) at 12 months
Number of Participants Who Experienced Aneurysm Recanalization

Full Information

First Posted
July 2, 2012
Last Updated
July 25, 2018
Sponsor
Penumbra Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01636453
Brief Title
The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
Official Title
The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penumbra Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wide-neck, Saccular Intracranial Aneurysms
Keywords
wide-neck, saccular, intracranial aneurysms, ICA, Stent assisted coiling, Liberty Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liberty Stent arm
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Stent assisted coiling with the Liberty Stent
Intervention 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
Primary Outcome Measure Information:
Title
Number of Participants With Raymond Class I Complete Obliteration at 12 Months
Description
Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).
Time Frame
At 12 months post-implant
Title
Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.
Time Frame
At 12 months post-implant
Secondary Outcome Measure Information:
Title
Number of Ipsilateral Ischemic Strokes
Description
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
Time Frame
At 12 months post-implant
Title
Number of Participants With Device-related Serious Adverse Events
Description
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.
Time Frame
During the procedure
Title
Number of Device Deployment Failures
Description
Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm
Time Frame
During the procedure
Title
Number of Device Migrations
Description
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.
Time Frame
12 months post-implant
Title
Number of Participants With Aneurysm Raymond Class I Occlusion Grading
Description
Raymond Class I Occlusion grading defined as complete obliteration of the aneurysm at 12 months.
Time Frame
At 12 months post-implant
Title
Number of Intracranial Hemorrhages
Description
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.
Time Frame
At 12 months post-implant
Title
Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2
Description
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.
Time Frame
At 12 months post-implant
Title
All Cause Mortality (Number of Deaths From Any Cause)
Time Frame
At 12 months post-implant
Title
Number of Retreatments
Description
Defined as any intervention after the completion of the initial stent assisted coiling procedure
Time Frame
At 12 months post-implant
Title
Number of Participants Who Experienced Device Patency
Description
Device patency (stenosis) at 12 months
Time Frame
at 12 months post-implant
Title
Number of Participants Who Experienced Aneurysm Recanalization
Time Frame
At 12 months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demtrius Lopes, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henry Woo, MD
Organizational Affiliation
Stony Brook University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8122
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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