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
2017
Nine‐month results of the BIOHELIX‐I clinical trial study: Evaluation of the PRO‐Kinetic Energy cobalt chromium bare‐metal stent system
Michael TT, Richardt G, Lansky A, Carney RJ, Khan MA, Shehadeh A, Zeymer U, Gupta S. Nine‐month results of the BIOHELIX‐I clinical trial study: Evaluation of the PRO‐Kinetic Energy cobalt chromium bare‐metal stent system. Catheterization And Cardiovascular Interventions 2017, 92: 1030-1039. PMID: 29271575, DOI: 10.1002/ccd.27434.Peer-Reviewed Original ResearchConceptsTarget vessel revascularizationCoronary artery diseaseIschemia-driven target vessel revascularizationBare metal stentsTarget vessel failureTVF ratePrimary endpointStent systemSymptomatic coronary artery diseaseTarget lesion revascularization rateSingle-arm clinical trialNine‐month resultsDual antiplatelet therapyLesion revascularization rateMean patient agePercutaneous coronary interventionSubset of patientsClinical trial studyPrespecified performance goalArm clinical trialCoronary stent systemDrug-eluting stentsMean lesion lengthMajority of implantsEligible patients
2013
First-in-Human Evaluation of a Bioabsorbable Polymer–Coated Sirolimus-Eluting Stent Imaging and Clinical Results of the DESSOLVE I Trial (DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesion in the Native Coronary Arteries)
Ormiston J, Webster M, Stewart J, Vrolix M, Whitbourn R, Donohoe D, Knape C, Lansky A, Attizzani GF, Fitzgerald P, Kandzari DE, Wijns W. First-in-Human Evaluation of a Bioabsorbable Polymer–Coated Sirolimus-Eluting Stent Imaging and Clinical Results of the DESSOLVE I Trial (DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesion in the Native Coronary Arteries). JACC Cardiovascular Interventions 2013, 6: 1026-1034. PMID: 24055443, DOI: 10.1016/j.jcin.2013.05.013.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAdultAgedAged, 80 and overAngina, StableAngina, UnstableAustraliaBelgiumCardiovascular AgentsChromium AlloysCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisCoronary StenosisCoronary VesselsDrug Therapy, CombinationDrug-Eluting StentsFemaleHumansMaleMiddle AgedMyocardial InfarctionNeointimaNew ZealandPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsPolymersProspective StudiesProsthesis DesignSeverity of Illness IndexSirolimusTime FactorsTomography, Optical CoherenceTreatment OutcomeUltrasonography, InterventionalConceptsStent late lumen lossLate lumen lossSirolimus-eluting stentsOptical coherence tomographyIntravascular ultrasoundMajor adverse cardiac eventsSymptomatic coronary artery diseaseCoherence tomographyComplete strut coverageNeointimal volume obstructionUnderwent repeat angiographyAdverse cardiac eventsDual antiplatelet therapyCoronary artery diseaseUnstable angina pectorisDrug-eluting stentsLong-term riskAntiplatelet therapyVolume obstructionCardiac eventsRepeat angiographyAdverse eventsAngina pectorisArtery diseaseI trial