Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, 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:
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
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: 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 July 22, 2014