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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Penumbra Inc.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01636453
First received: July 2, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Wide-neck, Saccular Intracranial Aneurysms
Device: Stent assisted coiling with the Liberty Stent
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms

Resource links provided by NLM:


Further study details as provided by Penumbra Inc.:

Primary Outcome Measures:
  • Complete aneurysmal occlusion of the treated target lesion on 12-month angiography in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture. [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: No ]
    Complete aneurysmal occlusion is defined by the method of Roy et al. (Class 1) (Stroke 2001;32:1998-2004).

  • Neurological death or major ipsilateral stroke at 12 months post treatment. [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All ipsilateral ischemic strokes [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: Yes ]
    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

  • Device-related serious adverse events [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]
    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.

  • Device deployment failure [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm

  • Device migration [ Time Frame: 12 months post-implant ] [ Designated as safety issue: Yes ]
    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.

  • Aneurysm occlusion [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: No ]
  • Intracranial hemorrhages [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: Yes ]
    Inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhages (symptomatic or asymptomatic). Symptomatic is defined as a 4 point or more increase in the NIHSS from baseline.

  • Functional outcome as defined by the modified Rankin Scale (mRS) [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: Yes ]
  • Retreatment [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: No ]
    Defined as any intervention after the completion of the initial stent assisted coiling procedure

  • Device patency [ Time Frame: at 12 months post-implant ] [ Designated as safety issue: No ]
    Patency will be defined by the WASID method.

  • Aneurysm recanalization [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636453

Contacts
Contact: Leticia Barraza, BS 510-748-3200 ext 267 leticia.barraza@penumbrainc.com
Contact: Siu Po Sit, PhD 5107483200 ext 221 siupo.sit@penumbrainc.com

Locations
United States, Colorado
Swedish Medical Center Not yet recruiting
Denver, Colorado, United States, 80112
Contact: David Loy, MD    314-709-2561    David.Loy@riaco.com   
Contact: Gwendolyn Dooley, FNP    303-726-9215    Gwendolyn.dooley@riaco.com   
Principal Investigator: David Loy, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Demetrius Lopes, MD    312-563-3394    brainaneurysm@me.com   
Contact: Christy Anton    (312) 942-1489    Christy_Anton@rush.edu   
Principal Investigator: Demetrius Lopes, MD         
United States, New York
Stony Brook University Medical Center Not yet recruiting
Stony Brook, New York, United States, 11794-8122
Contact: Henry Woo, MD    631-444-1610    Henry.Woo@sbumed.org   
Principal Investigator: Henry Woo, MD         
Sponsors and Collaborators
Penumbra Inc.
Investigators
Principal Investigator: Demtrius Lopes, MD Rush University Medical Center
Principal Investigator: Henry Woo, MD Stony Brook University Medical Center
  More Information

No publications provided

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT01636453     History of Changes
Other Study ID Numbers: CLP 5038 (IDE # G120050)
Study First Received: July 2, 2012
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Penumbra Inc.:
wide-neck
saccular
intracranial aneurysms
ICA
Stent assisted coiling
Liberty Stent

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014