Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms

This study is currently recruiting participants.
Verified February 2014 by Penumbra Inc.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01753388
First received: December 17, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.


Condition Intervention Phase
Wide Neck Intracranial Aneurysms
Device: Liberty Stent
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Penumbra Inc.:

Primary Outcome Measures:
  • Aneurysmal occlusion of the treated target lesion on 6-month angiography as defined by the method of Roy et al. (Stroke 2001;32:1998-2004). [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • Procedural device-related serious adverse events [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device patency and migration [ Time Frame: At 6 months post-procedure ] [ Designated as safety issue: Yes ]
  • Intracranial hemorrhage [ Time Frame: At 6 months post-procedure ] [ Designated as safety issue: Yes ]
  • Functional outcome as defined by the modified Rankin Scale (mRS) [ Time Frame: At 6 months post-procedure ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: At 6 months post-procedure ] [ Designated as safety issue: Yes ]
  • Retreatment [ Time Frame: At 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment by the Liberty Stent Device: Liberty Stent

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient from 18 to 85 years old
  • A symptomatic unruptured saccular intracranial aneurysm with a neck ≥4mm (or a dome to neck ratio <2) and a parent vessel diameter between 2.5 to 5.0 mm (inclusive) in both the anterior and posterior circulation of the brain, that is amenable to stent-assisted coiling. "Symptomatic" is defined as any neurological symptoms attributed to the target aneurysm.
  • Life expectancy >6 months
  • Signed Informed Consent

Exclusion Criteria:

  • Aneurysm with branches from the aneurysm base
  • Rapidly growing aneurysm
  • Daughter aneurysm
  • Aneurysm with partial or complex calcifications
  • Females who are nursing, 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 and use an approved highly efficient contraceptive method during the study
  • Multiple untreated cerebral aneurysms at study entry
  • Recent history of stroke, TIA, subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment
  • Previous brain surgery or irradiation of the target treatment territory that would, in the opinion of the investigator, interfere with the treatment of the target aneurysm
  • Admission platelet <150,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy
  • Underlying unstable Coronary Artery Disease, cardiac insufficiency or Myocardial Infarction
  • 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)
  • Patients unable to sign Informed Consent due to the emergency conditions of the intervention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753388

Contacts
Contact: Olivier Salem, PhD 33 6 82 33 05 06 osellam@penumbrainc.com
Contact: Siu Po Sit, PhD 510 748 3200 ext 221 siupo.sit@penumbrainc.com

Locations
Germany
Asklepios Klinik Altona Recruiting
Hamburg, Germany
Contact: Prof. Dr. med. Bernd Eckert         
Principal Investigator: Prof. Dr. med. Bernd Eckert         
Universitätsklinikum des Saarlandes Recruiting
Homburg/Saar, Germany
Contact: Prof. Dr. med. Wolfgang Reith         
Principal Investigator: Prof. Dr. med. Wolfgang Reith         
Universitätsklinikum Magdeburg A. ö. R. Recruiting
Magdeburg, Germany
Contact: Prof. Dr. med. Martin Skalej         
Principal Investigator: Prof. Dr. med. Martin Skalej         
Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen Recruiting
Recklinghausen, Germany
Contact: PD Dr. med. Werner Weber         
Principal Investigator: PD Dr. med Werner Weber         
Sponsors and Collaborators
Penumbra Inc.
Investigators
Principal Investigator: Werner Weber, PD Dr. med Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
  More Information

No publications provided

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT01753388     History of Changes
Other Study ID Numbers: CLP 4928, CLP 4928
Study First Received: December 17, 2012
Last Updated: February 19, 2014
Health Authority: Germany:Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM)

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 April 22, 2014