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| ID | Type | Description | Link |
|---|---|---|---|
| CLP 4928 | Other Identifier | Penumbra Inc |
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The study was never initiated
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment by the Liberty Stent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liberty Stent | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Device patency and migration | At 6 months post-procedure | |
| Intracranial hemorrhage | At 6 months post-procedure | |
| Functional outcome as defined by the modified Rankin Scale (mRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner Weber, PD Dr. med | Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asklepios Klinik Altona | Hamburg | Germany | ||||
| Universitätsklinikum des Saarlandes |
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| At 6 months post-procedure |
| All cause mortality | At 6 months post-procedure |
| Retreatment | At 6 months |
| Homburg/Saar |
| Germany |
| Universitätsklinikum Magdeburg A. ö. R. | Magdeburg | Germany |
| Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen | Recklinghausen | Germany |