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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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
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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