Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
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ClinicalTrials.gov Identifier: NCT01753388 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 20, 2012
Last Update Posted
: September 28, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Wide Neck Intracranial Aneurysms | Device: Liberty Stent | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
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 |
Study Start Date : | December 2012 |
Estimated Primary Completion Date : | June 2017 |
Estimated Study Completion Date : | June 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment by the Liberty Stent | Device: Liberty Stent |
- 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 ]
- 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 ]

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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753388
Germany | |
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 |
Principal Investigator: | Werner Weber, PD Dr. med | Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen |
Responsible Party: | Penumbra Inc. |
ClinicalTrials.gov Identifier: | NCT01753388 History of Changes |
Other Study ID Numbers: |
CLP 4928 CLP 4928 ( Other Identifier: Penumbra Inc ) |
First Posted: | December 20, 2012 Key Record Dates |
Last Update Posted: | September 28, 2016 |
Last Verified: | September 2016 |
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 |