Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up
| Autor: | Thomas Liebig, Saleh M Lamin, Hannes Nordmeyer, Swarupsinh Chavda, René Chapot, Elisa Ciceri, Christoph Kabbasch, Konstantinos Lagios, Luc Stockx, Mario Martínez-Galdámez, Edoardo Boccardi, Thierry Boulanger, Mariangela Piano, Giuseppe Faragò |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors medicine.medical_treatment Pipeline (computing) 1 year follow up 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Aneurysm Recurrence Clinical endpoint Medicine Effective treatment Humans Embolization Prospective Studies Stroke Aged pipeline embolization device phosphorylcholine business.industry Intracranial Aneurysm General Medicine Middle Aged medicine.disease Embolization Therapeutic Surgery Blood Vessel Prosthesis Cerebral Angiography New Devices Treatment Outcome Multicenter study Retreatment Female Neurology (clinical) Radiology business 030217 neurology & neurosurgery Follow-Up Studies |
| Zdroj: | Journal of Neurointerventional Surgery |
| ISSN: | 1759-8486 1759-8478 |
| Popis: | PurposeThe Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs.Materials and methodsThe Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year.ResultsFifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (ConclusionsOur 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs.Trial registration numberNCT02390037 |
| Databáze: | OpenAIRE |
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