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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Wide Neck Intracranial Aneurysms	Device: Liberty Stent	Phase 2

Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Treatment by the Liberty Stent	Device: Liberty Stent

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
2. Procedural device-related serious adverse events [ Time Frame: During the procedure ]

Secondary Outcome Measures :

1. Device patency and migration [ Time Frame: At 6 months post-procedure ]
2. Intracranial hemorrhage [ Time Frame: At 6 months post-procedure ]
3. Functional outcome as defined by the modified Rankin Scale (mRS) [ Time Frame: At 6 months post-procedure ]
4. All cause mortality [ Time Frame: At 6 months post-procedure ]
5. Retreatment [ Time Frame: At 6 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

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

Sponsors and Collaborators

Penumbra Inc.

Investigators

Principal Investigator:	Werner Weber, PD Dr. med	Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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