2020
Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology.
Chang CC, Kogame N, Onuma Y, Byrne RA, Capodanno D, Windecker S, Morel MA, Cutlip DE, Krucoff MW, Stone GW, Lansky AJ, Mehran R, Spitzer E, Fraser AG, Baumbach A, Serruys PW. Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology. EuroIntervention 2020, 15: 1190-1198. PMID: 31475907, DOI: 10.4244/eij-d-19-00552.Peer-Reviewed Original ResearchConceptsDevice success rateDrug-eluting stentsPercutaneous coronary intervention trialsCoronary intervention trialsDevice successIntervention trialsClinical trialsSuccess rateSymptomatic coronary artery diseasePercutaneous coronary interventionAdverse clinical eventsCoronary artery diseasePercutaneous Cardiovascular InterventionsDifferent trialsRevascularisation proceduresCoronary interventionAngiographic outcomesArtery diseaseClinical eventsComparative trialsEndpoint definitionsDrug AdministrationCardiovascular interventionsPerformance endpointEuropean Association
2013
Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit
Meller SM, Baumbach A, Voros S, Mullen M, Lansky AJ. Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit. BMC Medicine 2013, 11: 257. PMID: 24330754, PMCID: PMC4029193, DOI: 10.1186/1741-7015-11-257.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve implantationAortic valve implantationLesion volumeCerebral eventsValve implantationNew lesionsClinical studiesSurrogate endpointsAppropriate endpointsPrimary efficacy endpointDiffusion-weighted magnetic resonance imagingCerebral protection devicesUseful surrogate endpointTotal lesion volumeMagnetic resonance imagingSample size limitationsEfficacy endpointClinical outcomesDevice successOngoing trialsNeurological protectionClinical eventsResonance imagingMRI valuesConsensus opinion