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dc.contributor.authorHanel, Ricardo A.
dc.contributor.authorPuri, Ajit S.
dc.date2022-08-11T08:10:48.000
dc.date.accessioned2022-08-23T17:20:46Z
dc.date.available2022-08-23T17:20:46Z
dc.date.issued2019-07-15
dc.date.submitted2019-08-08
dc.identifier.citation<p>J Neurointerv Surg. 2019 Jul 15. pii: neurintsurg-2019-015091. doi: 10.1136/neurintsurg-2019-015091. [Epub ahead of print] <a href="https://doi.org/10.1136/neurintsurg-2019-015091">Link to article on publisher's site</a></p>
dc.identifier.issn1759-8478 (Linking)
dc.identifier.doi10.1136/neurintsurg-2019-015091
dc.identifier.pmid31308197
dc.identifier.urihttp://hdl.handle.net/20.500.14038/48376
dc.description<p>Full author list omitted for brevity. For the full list of authors, see article.</p>
dc.description.abstractBACKGROUND: Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications. OBJECTIVE: To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms. METHODS: PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring < /=12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis ( < /=50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death. RESULTS: A total of 141 patients were treated with PEDs (mean age 54.6+/-11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0+/-1.92 mm, and 84.4% (119/141) measured < 7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1+/-0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140). CONCLUSIONS: Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications. TRIAL REGISTRATION: NCT02186561.
dc.language.isoen_US
dc.relation<p><a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=31308197&dopt=Abstract">Link to Article in PubMed</a></p>
dc.relation.urlhttps://doi.org/10.1136/neurintsurg-2019-015091
dc.subjectaneurysm
dc.subjectartery
dc.subjectbrain
dc.subjectflow diverter
dc.subjectintervention
dc.subjectAnalytical, Diagnostic and Therapeutic Techniques and Equipment
dc.subjectCardiovascular Diseases
dc.subjectCardiovascular System
dc.subjectHealth Services Administration
dc.subjectNeurology
dc.subjectRadiology
dc.titleProspective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results
dc.typeJournal Article
dc.source.journaltitleJournal of neurointerventional surgery
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/radiology_pubs/486
dc.identifier.contextkey15082123
html.description.abstract<p>BACKGROUND: Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.</p> <p>OBJECTIVE: To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.</p> <p>METHODS: PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring < /=12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis ( < /=50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.</p> <p>RESULTS: A total of 141 patients were treated with PEDs (mean age 54.6+/-11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0+/-1.92 mm, and 84.4% (119/141) measured < 7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1+/-0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140).</p> <p>CONCLUSIONS: Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.</p> <p>TRIAL REGISTRATION: NCT02186561.</p>
dc.identifier.submissionpathradiology_pubs/486
dc.contributor.departmentNew England Center for Stroke Research, Department of Radiology


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