2021
Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II
Nazif TM, Moses J, Sharma R, Dhoble A, Rovin J, Brown D, Horwitz P, Makkar R, Stoler R, Forrest J, Messé S, Dickerman S, Brennan J, Zivadinov R, Dwyer MG, Lansky AJ, Investigators R. Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II. JACC Cardiovascular Interventions 2021, 14: 515-527. PMID: 33663779, DOI: 10.1016/j.jcin.2020.11.011.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementSafety endpointValve replacementProcedure-related ischemic strokeCerebral embolic protectionComposite efficacy endpointPrimary safety endpointCerebral embolizationCerebral protectionEfficacy endpointII trialCerebral injuryIschemic strokeEmbolic protectionPatientsDrug AdministrationUS sitesU.S. FoodEndpointData reviewTrialsMulticenterEmbolizationInjury
2020
Long‐term serial functional evaluation after implantation of the Fantom sirolimus‐eluting bioresorbable coronary scaffold
Saito Y, Cristea E, Bouras G, Abizaid A, Lutz M, Carrié D, Weber‐Albers J, Dudek D, Anderson J, Lansky A, Investigators T. Long‐term serial functional evaluation after implantation of the Fantom sirolimus‐eluting bioresorbable coronary scaffold. Catheterization And Cardiovascular Interventions 2020, 97: 431-436. PMID: 32077590, DOI: 10.1002/ccd.28804.Peer-Reviewed Original ResearchConceptsPost-percutaneous coronary interventionQuantitative flow ratioBioresorbable coronary scaffoldTarget vessel revascularizationVessel revascularizationFunctional ischemiaStable coronary artery diseaseTime of revascularizationCoronary artery diseaseFractional flow reserveQFR assessmentII trialAngiographic outcomesCoronary interventionUnstable anginaArtery diseaseQFR valueWire-based fractional flow reserveSignificant lesionsFlow reservePatientsTarget vesselRevascularizationQFR analysisFunctional evaluation
2015
Bioabsorbable polymer‐coated sirolimus‐eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub‐study
Rusinaru D, Vrolix M, Verheye S, Chowdhary S, Schoors D, Di Mario C, Desmet W, Donohoe DJ, Ormiston JA, Knape C, Bezerra H, Lansky A, Wijns W, Investigators O. Bioabsorbable polymer‐coated sirolimus‐eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub‐study. Catheterization And Cardiovascular Interventions 2015, 86: 1141-1150. PMID: 25044635, DOI: 10.1002/ccd.25610.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAgedCardiac Pacing, ArtificialCardiovascular AgentsCoronary AngiographyCoronary Artery DiseaseCoronary VesselsDrug-Eluting StentsEuropeFemaleHistorically Controlled StudyHumansMaleMiddle AgedNew ZealandPercutaneous Coronary InterventionPolymersProspective StudiesSingle-Blind MethodSirolimusTime FactorsTreatment OutcomeVasoconstrictionVasodilationConceptsZotarolimus-eluting stentsDrug-eluting stentsCoronary vasomotionII trialVasomotor dysfunctionFirst-generation drug-eluting stentsEndeavor zotarolimus-eluting stentsGeneration drug-eluting stentsCoronary vasomotor dysfunctionSirolimus-eluting stentsQuantitative coronary angiographyVessel diameterMaximal pacingCoronary angiographyZES groupCoronary arteryVasomotor responsesHistorical groupStent edgeNormal vasomotionPatientsPercent changeReference segmentsVasomotionSES groupRandomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial.
Wijns W, Vrolix M, Verheye S, Schoors D, Slagboom T, Gosselink M, Benit E, Donohoe D, Knape C, Attizzani GF, Lansky AJ, Ormiston J. Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial. EuroIntervention 2015, 10: 1383-90. PMID: 24801119, DOI: 10.4244/eijy14m05_03.Peer-Reviewed Original ResearchConceptsZotarolimus-eluting stentsLate lumen lossStent late lumen lossOptical coherence tomographyII trialMajor adverse cardiac eventsMean late lumen lossClinical safety endpointPrimary efficacy hypothesisAdverse cardiac eventsPrimary efficacy endpointStent thrombosis ratesMean neointimal thicknessSirolimus-eluting stentsQuantitative coronary angiographyZES patientsEfficacy endpointPrimary endpointSafety endpointVolume obstructionCardiac eventsCoronary angiographyThrombosis rateZES groupStrut coverage
2014
TCT-605 Safety and Efficacy of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Lesions: 2-Year Results from the Prospectively Patient-Level Pooled Analysis of the TARGET I and TARGET II Trials
Zhao Y, Xu B, Yang Y, Zhang R, Changsheng M, Li H, Huo Y, Lansky A, Leon M, Gao R. TCT-605 Safety and Efficacy of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Lesions: 2-Year Results from the Prospectively Patient-Level Pooled Analysis of the TARGET I and TARGET II Trials. Journal Of The American College Of Cardiology 2014, 64: b176-b177. DOI: 10.1016/j.jacc.2014.07.670.Peer-Reviewed Original Research
2013
TCT-181 Safety and Efficacy of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Lesions: 12-Month Results from the Prospectively Patient-Level Pooled Analysis of the TARGET I and TARGET II Trials
Gao R, Xu B, Lansky A, Yang Y, Zhang R, Changsheng M, Li H, Chen S, Han Y, Yuan Z, Huo Y, Li W, Zhao Y, Leon M. TCT-181 Safety and Efficacy of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Lesions: 12-Month Results from the Prospectively Patient-Level Pooled Analysis of the TARGET I and TARGET II Trials. Journal Of The American College Of Cardiology 2013, 62: b59. DOI: 10.1016/j.jacc.2013.08.915.Peer-Reviewed Original Research
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
2005
Sirolimus-Eluting versus Bare Nitinol Stent for Obstructive Superficial Femoral Artery Disease: The SIROCCO II Trial
Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Mudde C, Tielemans H, Bérégi JP. Sirolimus-Eluting versus Bare Nitinol Stent for Obstructive Superficial Femoral Artery Disease: The SIROCCO II Trial. Journal Of Vascular And Interventional Radiology 2005, 16: 331-338. PMID: 15758128, DOI: 10.1097/01.rvi.0000151260.74519.ca.Peer-Reviewed Original ResearchConceptsSirolimus-eluting stent groupStent groupBare stent groupMean lumen diameterSignificant differencesLumen diameterSuperficial femoral artery diseaseSuperficial femoral artery obstructionChronic limb ischemiaFemoral artery diseaseFemoral artery obstructionAnkle-brachial indexBinary restenosis rateDouble-blind studySymptoms of claudicationBare nitinol stentsSirolimus-eluting stentsStandard interventional techniquesArtery obstructionPrimary endpointII trialAdverse eventsAngiographic outcomesArtery diseaseLimb ischemia
2004
1101-44 Effect of everolimus-eluting stents in preventing neointimal hyperplasia: An intravascular ultrasound analysis from the FUTURE II trial
Sonoda S, Grube E, Shimada Y, Hassan A, Honda Y, Yock P, Chan C, Honda H, Kar S, Hauptmann K, Storger H, Lansky A, Fitzgerald P. 1101-44 Effect of everolimus-eluting stents in preventing neointimal hyperplasia: An intravascular ultrasound analysis from the FUTURE II trial. Journal Of The American College Of Cardiology 2004, 43: a66. DOI: 10.1016/s0735-1097(04)90276-8.Peer-Reviewed Original Research