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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Penumbra Inc. Identifier:
First received: December 17, 2012
Last updated: September 26, 2016
Last verified: September 2016
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: Intervention Model: Single Group Assignment
Masking: None (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 ]
  • Procedural device-related serious adverse events [ Time Frame: During the procedure ]

Secondary Outcome Measures:
  • Device patency and migration [ Time Frame: At 6 months post-procedure ]
  • Intracranial hemorrhage [ Time Frame: At 6 months post-procedure ]
  • Functional outcome as defined by the modified Rankin Scale (mRS) [ Time Frame: At 6 months post-procedure ]
  • All cause mortality [ Time Frame: At 6 months post-procedure ]
  • Retreatment [ Time Frame: At 6 months ]

Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment by the Liberty Stent Device: Liberty Stent


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01753388

Asklepios Klinik Altona
Hamburg, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany
Universitätsklinikum Magdeburg A. ö. R.
Magdeburg, Germany
Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
Recklinghausen, Germany
Sponsors and Collaborators
Penumbra Inc.
Principal Investigator: Werner Weber, PD Dr. med Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
  More Information

Responsible Party: Penumbra Inc. Identifier: NCT01753388     History of Changes
Other Study ID Numbers: CLP 4928
CLP 4928 ( Other Identifier: Penumbra Inc )
Study First Received: December 17, 2012
Last Updated: September 26, 2016

Additional relevant MeSH terms:
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on September 19, 2017