2022
Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.
Jagielak D, Targonski R, Frerker C, Abdel-Wahab M, Wilde J, Werner N, Lauterbach M, Leick J, Grygier M, Misterski M, Erglis A, Narbute I, Witkowski AR, Adam M, Frank D, Gatto F, Schmidt T, Lansky AJ. Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial. EuroIntervention 2022, 18: 590-597. PMID: 35608032, PMCID: PMC10241272, DOI: 10.4244/eij-d-22-00238.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve implantationAortic valve implantationLesion volumeValve implantationTechnical successC trialSingle lesionCerebral embolic protection devicesPerformance endpointBrain diffusion-weighted magnetic resonance imagingLarge single lesionsPrimary safety endpointBrain lesion volumeDiffusion-weighted magnetic resonance imagingCerebral protection systemSingle-arm studyEmbolic protection devicesPrimary performance endpointRate of deathMagnetic resonance imagingTAVI casesTAVI patientsVARC-2Cerebrovascular eventsPrimary endpoint
2010
Comparison of Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients Undergoing Multilesion and Multivessel Intervention The SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) Randomized Trials
Kereiakes DJ, Sudhir K, Hermiller JB, Gordon PC, Ferguson J, Yaqub M, Sood P, Su X, Yakubov S, Lansky AJ, Stone GW. Comparison of Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients Undergoing Multilesion and Multivessel Intervention The SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) Randomized Trials. JACC Cardiovascular Interventions 2010, 3: 1229-1239. PMID: 21232716, DOI: 10.1016/j.jcin.2010.09.014.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryAntineoplastic Agents, PhytogenicCoronary Artery BypassCoronary Artery DiseaseDrug-Eluting StentsEverolimusFemaleHumansImmunosuppressive AgentsKaplan-Meier EstimateMaleMiddle AgedPaclitaxelRandomized Controlled Trials as TopicSirolimusTime FactorsUnited StatesConceptsPaclitaxel-eluting stentsIschemia-driven target lesion revascularizationTarget vessel myocardial infarctionSPIRIT IV trialTarget lesion revascularizationVessel myocardial infarctionLesion revascularizationMultivessel diseaseMultivessel interventionAbsolute benefitMyocardial infarctionOptimal revascularization strategySingle-vessel interventionDe novo lesionsReference vessel diameterEverolimus-ElutingMultilesion interventionEfficacy outcomesNovo lesionsRevascularization strategyCoronary diseaseClinical outcomesCoronary arteryClinical safetySingle lesion