Clinical trial NCT01636453: 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
Overall status: COMPLETED
Phase: NA
Conditions: Wide-neck, Saccular Intracranial Aneurysms
Keywords: wide-neck
saccular
intracranial aneurysms
ICA
Stent assisted coiling
Liberty Stent
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Number of Participants With Raymond Class I Complete Obliteration at 12 Months
timeFrame: At 12 months post-implant
measure: Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.
timeFrame: At 12 months post-implant
Secondary outcomes:
measure: Number of Ipsilateral Ischemic Strokes
timeFrame: At 12 months post-implant
measure: Number of Participants With Device-related Serious Adverse Events
timeFrame: During the procedure
measure: Number of Device Deployment Failures
timeFrame: During the procedure
measure: Number of Device Migrations
timeFrame: 12 months post-implant
measure: Number of Participants With Aneurysm Raymond Class I Occlusion Grading
timeFrame: At 12 months post-implant
measure: Number of Intracranial Hemorrhages
timeFrame: At 12 months post-implant
measure: Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2
timeFrame: At 12 months post-implant
measure: All Cause Mortality (Number of Deaths From Any Cause)
timeFrame: At 12 months post-implant
measure: Number of Retreatments
timeFrame: At 12 months post-implant
measure: Number of Participants Who Experienced Device Patency
timeFrame: at 12 months post-implant
measure: Number of Participants Who Experienced Aneurysm Recanalization
timeFrame: At 12 months post-implant
Other outcomes:
Locations:
city: Denver
country: United States
facility: Swedish Medical Center
state: Colorado
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
Study officials:
affiliation: Rush University Medical Center
name: Demtrius Lopes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stony Brook University Medical Center
name: Henry Woo, MD
role: PRINCIPAL_INVESTIGATOR
References: