2018
Optical coherence tomography substudy of a prospective multicentre randomised post-market trial to assess the safety and effectiveness of the Firehawk cobalt-chromium coronary stent (rapamycin target-eluting) system for the treatment of atherosclerotic lesions: TARGET All Comers.
Baumbach A, Lansky AJ, Onuma Y, Asano T, Johnson T, Anderson R, Kiemeneij F, Zheng M, Van Royen N, Slagboom T, Vlachojannis G, Xu B, Serruys P, Wijns W. Optical coherence tomography substudy of a prospective multicentre randomised post-market trial to assess the safety and effectiveness of the Firehawk cobalt-chromium coronary stent (rapamycin target-eluting) system for the treatment of atherosclerotic lesions: TARGET All Comers. EuroIntervention 2018, 14: 1121-1128. PMID: 29901441, DOI: 10.4244/eij-d-18-00226.Peer-Reviewed Original ResearchConceptsOptical coherence tomography substudyPrimary endpointProspective multicentreStrut coveragePost-market trialDP-DESNeointimal thicknessDurable polymer drug-eluting stentsComers patient populationComplete strut coverageLate DES thrombosisSirolimus-eluting stentsStent strut coverageMean neointimal thicknessCoronary stent systemDrug-eluting stentsOCT substudyConsecutive patientsDES thrombosisPersistent inflammationPatient populationBP-DESNeointimal coverageEndothelial healingAtherosclerotic lesionsTCT-624 A prospective multicenter randomized post-market trial evaluating a novel Cobalt Chrome Rapamycin Drug Eluting Stent: Subgroup Analysis of the TARGET All Comers Trial
Lansky A, Wijns W, Xu B, Kelbaek H, van Royen N, Zheng M, Artus-Jacenko L, Knaapen P, Slagboom T, Vlachojannis G, Arkenbout K, Holmvang L, Janssens L, Ochala A, Brugaletta S, Bruder O, Berti S, Barbato E, Toth G, Maillard L, Valina C, Buszman P, Johnson T, Thiele H, Baumbach A. TCT-624 A prospective multicenter randomized post-market trial evaluating a novel Cobalt Chrome Rapamycin Drug Eluting Stent: Subgroup Analysis of the TARGET All Comers Trial. Journal Of The American College Of Cardiology 2018, 72: b249-b250. DOI: 10.1016/j.jacc.2018.08.1826.Peer-Reviewed Original Research
2017
Post‐marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross‐sectional study
Zeitoun J, Baron G, Vivot A, Atal I, Downing NS, Ross JS, Ravaud P. Post‐marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross‐sectional study. International Journal Of Cancer 2017, 142: 414-423. PMID: 28929484, DOI: 10.1002/ijc.31061.Peer-Reviewed Original ResearchConceptsPost-marketing trialsPrimary outcomeNovel anticancer agentsPost-market researchAnticancer agentsSupplemental indicationsCross-sectional studyPost-marketing researchEuropean Medicines AgencyCross-sectional analysisTypes of cancerPost-market trialClinical endpointsHematologic malignanciesKidney cancerSolid cancersSurrogate endpointsUS FoodDrug AdministrationMedicines AgencyOverall populationCancerTrialsPublication rateOutcomes
2016
CRT-200.54 Evaluation of 2-year Clinical Outcomes From Post-market Trials With Everolimus-eluting Cobalt Chromium Stents in Diabetics
Ng V, Seth A, Alkhalil I, Grube E, Morice M, Mao V, Deible R, Sudhir K, Lansky A. CRT-200.54 Evaluation of 2-year Clinical Outcomes From Post-market Trials With Everolimus-eluting Cobalt Chromium Stents in Diabetics. JACC Cardiovascular Interventions 2016, 9: s20. DOI: 10.1016/j.jcin.2015.12.086.Peer-Reviewed Original Research
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