2021
A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial
Lansky AJ, Makkar R, Nazif T, Messé S, Forrest J, Sharma R, Schofer J, Linke A, Brown D, Dhoble A, Horwitz P, Zang M, DeMarco F, Rajagopal V, Dwyer MG, Zivadinov R, Stella P, Rovin J, Parise H, Kodali S, Baumbach A, Moses J. A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial. European Heart Journal 2021, 42: 2670-2679. PMID: 34000004, DOI: 10.1093/eurheartj/ehab213.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementEfficacy endpointCerebral embolic protection devicesTranscatheter aortic valve implantationCentral nervous system injuryCerebral embolic lesionsCerebral ischemic lesionsHealth Stroke ScalePrimary efficacy endpointPrimary safety outcomeAortic valve replacementAortic valve implantationEmbolic protection devicesNervous system injuryDiffusion-weighted magnetic resonanceMontreal Cognitive AssessmentEffectiveness endpointCause mortalityCerebral protectionSafety endpointStroke ScaleValve implantationValve replacementI trialIschemic lesions
2019
Clinical outcomes of complex lesions treated with an abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent and durable polymer everolimus‐eluting stent
Saito Y, Baumbach A, Wijns W, Xu B, Kelbæk H, Zheng M, Morel M, Anderson R, Schächinger V, Lansky A, Investigators T. Clinical outcomes of complex lesions treated with an abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent and durable polymer everolimus‐eluting stent. Catheterization And Cardiovascular Interventions 2019, 96: 1023-1028. PMID: 31769161, DOI: 10.1002/ccd.28609.Peer-Reviewed Original ResearchConceptsHigh-risk patientsClinical outcomesComer studyI trialDurable polymer everolimus-eluting stentsTarget vessel myocardial infarctionSirolimus-eluting coronary stentYear clinical outcomesTarget lesion failureVessel myocardial infarctionLow-risk patientsWorse clinical outcomesEverolimus-eluting stentsHigh-risk groupLow-risk groupStrict eligibility criteriaFIREHAWK stentLesion failurePrimary endpointRandomized trialsMyocardial infarctionRisk groupsInclusion criteriaComplex lesionsXIENCE stent
2013
TCT-20 Two-Year Clinical Follow-Up of the FIREHAWK Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent in the Treatment of Patients with De Novo Native Coronary Artery Lesions: The TARGET I Trial
Xu B, Gao R, Lansky A, Yang Y, Changsheng M, Han Y, Chen S, Li H, Zhang R, Fu G, Yuan Z, Huo Y, Li W, Zhao Y, Leon M. TCT-20 Two-Year Clinical Follow-Up of the FIREHAWK Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent in the Treatment of Patients with De Novo Native Coronary Artery Lesions: The TARGET I Trial. Journal Of The American College Of Cardiology 2013, 62: b7-b8. DOI: 10.1016/j.jacc.2013.08.748.Peer-Reviewed Original ResearchDe novo native coronary artery lesionsBiodegradable Polymer Sirolimus-Eluting StentNovo native coronary artery lesionsNative coronary artery lesionsCoronary artery lesionsSirolimus-Eluting StentsTreatment of patientsTwo-Year ClinicalAbluminal grooveArtery lesionsI trialPatientsClinicalLesionsStentsTrialsFirst-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 trialA randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial.
Gao RL, Xu B, Lansky AJ, Yang YJ, Ma CS, Han YL, Chen SL, Li H, Zhang RY, Fu GS, Yuan ZY, Jiang H, Huo Y, Li W, Zhang YJ, Leon MB. A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial. EuroIntervention 2013, 9: 75-83. PMID: 23685298, DOI: 10.4244/eijv9i1a12.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAgedAnalysis of VarianceAntineoplastic AgentsChinaChi-Square DistributionCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisCoronary StenosisCoronary ThrombosisDrug-Eluting StentsEverolimusFemaleHumansLeast-Squares AnalysisMaleMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionPolymersPredictive Value of TestsProspective StudiesProsthesis DesignSirolimusTime FactorsTreatment OutcomeConceptsIschaemia-driven target lesion revascularisationStent late lumen lossTarget vessel myocardial infarctionLate lumen lossTarget lesion failureSingle de novo coronary lesionsDe novo coronary lesionsNovo coronary lesionsCoronary lesionsPrimary endpointCardiac deathI trialNovel abluminal groove-filled biodegradable polymer sirolimus-eluting stentSingle de novo native coronary lesionsDe novo native coronary lesionsBiodegradable polymer sirolimus-eluting stentsNine monthsNative coronary lesionsProbable stent thrombosisTarget lesion revascularisationVessel myocardial infarctionSirolimus-eluting stentsNon-inferiority trialLesion revascularisationEES group
2007
Randomized, double‐blind, multicenter study of the polymer‐based 17‐β estradiol‐eluting stent for treatment of native coronary artery lesions: Six‐month results of the ETHOS I trial
Abizaid A, Chaves Á, Leon MB, Hauptmann K, Mehran R, Lansky AJ, Baumbach W, Shankar H, Muller R, Feres F, Sousa AG, Sousa JE, Grube E. Randomized, double‐blind, multicenter study of the polymer‐based 17‐β estradiol‐eluting stent for treatment of native coronary artery lesions: Six‐month results of the ETHOS I trial. Catheterization And Cardiovascular Interventions 2007, 70: 654-660. PMID: 17932898, DOI: 10.1002/ccd.21210.Peer-Reviewed Original ResearchConceptsStent volume obstructionIntravascular ultrasoundVolume obstructionI trialCoronary lesionsSingle de novo native coronary lesionsDe novo native coronary lesionsMean reference vessel diameterMajor adverse cardiac eventsNative coronary artery lesionsBinary angiographic restenosisAdverse cardiac eventsNative coronary lesionsPrimary end pointCoronary artery lesionsReference vessel diameterSix-month resultsStent late lossTreatment of patientsBare metal stentsMean lesion lengthLesion revascularizationAngiographic restenosisPrimary endpointSecondary endpointsCobalt chromium stent with antiproliferative for restenosis trial in India (COSTAR I).
Kaul U, Gupta RK, Mathur A, Dani S, Sapra R, Nayak PR, Lansky A, Cristea E, Carlier S, Gambone L, Litvack F. Cobalt chromium stent with antiproliferative for restenosis trial in India (COSTAR I). Indian Heart Journal 2007, 59: 165-72. PMID: 19122251.Peer-Reviewed Original ResearchConceptsStent late lossGroup 2Group 1Late lossI trialCoronary lesionsGroup 3De novo coronary lesionsSegment late lossBinary restenosis rateNative coronary lesionsNovo coronary lesionsMulti-center registryCoronary stent systemRelease formulationExtended-release formulationSmall-caliber vesselsCobalt-chromium stentNovo lesionsPrimary endpointRestenosis TrialRestenosis rateClinical outcomesFeasibility trialClinical results
2006
Effect of Everolimus-Eluting Stents in Different Vessel Sizes (from the Pooled FUTURE I and II Trials)
Tsuchiya Y, Lansky AJ, Costa RA, Mehran R, Pietras C, Shimada Y, Sonoda S, Cristea E, Negoita M, Dangas GD, Moses JW, Leon MB, Fitzgerald PJ, Müller R, Störger H, Hauptmann KE, Grube E. Effect of Everolimus-Eluting Stents in Different Vessel Sizes (from the Pooled FUTURE I and II Trials). The American Journal Of Cardiology 2006, 98: 464-469. PMID: 16893698, DOI: 10.1016/j.amjcard.2006.02.054.Peer-Reviewed Original ResearchMeSH KeywordsAgedBlood Vessel Prosthesis ImplantationCoated Materials, BiocompatibleCoronary AngiographyCoronary RestenosisCoronary VesselsEverolimusFemaleFollow-Up StudiesHumansImmunosuppressive AgentsMaleMiddle AgedProspective StudiesProsthesis DesignSirolimusStentsTreatment OutcomeUltrasonography, InterventionalConceptsBare metal stentsDe novo coronary lesionsNovo coronary lesionsCoronary lesionsNeointimal proliferationStent late lumen lossMid-term outcomesLate lumen lossEverolimus-Eluting StentsQuantitative coronary angiographyMinimum lumen areaVessel sizeII trialCoronary angiographyI trialIncomplete appositionLumen lossStent thrombosisAneurysm formationStent restenosisIntravascular ultrasoundMetal stentsReference diameterLumen areaPatients
2004
Six- and Twelve-Month Results From First Human Experience Using Everolimus-Eluting Stents With Bioabsorbable Polymer
Grube E, Sonoda S, Ikeno F, Honda Y, Kar S, Chan C, Gerckens U, Lansky AJ, Fitzgerald PJ. Six- and Twelve-Month Results From First Human Experience Using Everolimus-Eluting Stents With Bioabsorbable Polymer. Circulation 2004, 109: 2168-2171. PMID: 15123533, DOI: 10.1161/01.cir.0000128850.84227.fd.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnticoagulantsCatheterizationCineangiographyCoated Materials, BiocompatibleComorbidityCoronary AngiographyCoronary RestenosisCoronary StenosisDrug ImplantsEverolimusFemaleFollow-Up StudiesGrowth InhibitorsHumansHyperplasiaImmunosuppressive AgentsLactic AcidMaleMiddle AgedMyocardial InfarctionPolyestersPolymersProspective StudiesSingle-Blind MethodSirolimusStainless SteelStentsTreatment OutcomeTunica IntimaUltrasonography, InterventionalConceptsEverolimus-eluting stentsBare metal stentsRestenosis rateMajor adverse cardiac event ratesAdverse cardiac event ratesDe novo coronary lesionsMajor adverse cardiac eventsPercent neointimal volumeSegment restenosis rateAdverse cardiac eventsCardiac event rateNovo coronary lesionsStent restenosis rateTwelve-month resultsFirst human experienceIntravascular ultrasound analysisInitial clinical experienceLate stent malappositionLate stent thrombosisStent neointimal hyperplasiaSignificant reductionRestenosis reductionCardiac eventsI trialCoronary lesions