Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
Phase 2
Withdrawn
- Conditions
- Wide Neck Intracranial Aneurysms
- Interventions
- Device: Liberty Stent
- Registration Number
- NCT01753388
- Lead Sponsor
- Penumbra Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment by the Liberty Stent Liberty Stent -
- Primary Outcome Measures
Name Time Method 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). 6 months post-procedure Procedural device-related serious adverse events During the procedure
- Secondary Outcome Measures
Name Time Method Device patency and migration At 6 months post-procedure Retreatment At 6 months Intracranial hemorrhage At 6 months post-procedure Functional outcome as defined by the modified Rankin Scale (mRS) At 6 months post-procedure All cause mortality At 6 months post-procedure
Trial Locations
- Locations (4)
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