2024
A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF)
Kobayashi T, Secemsky E, Klein A, Faintuch S, Bulman J, Weinstein J, Bitton-Faiwiszewski Y, Bisharat M, Metzger D, Rosenberg R, Weinberg I, Vadlamudi V, Matthai W, Saleh A, Cristea E, Lansky A, Giri J. A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF). Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 102049. PMID: 39132596, PMCID: PMC11307881, DOI: 10.1016/j.jscai.2024.102049.Peer-Reviewed Original ResearchIntermediate-risk PELife-threatening bleedingPulmonary embolismRV/LV ratioAcute PEAdverse eventsThrombectomy catheterPostprocedure computed tomography angiographyTreatment of acute PEDevice-related serious adverse eventsTreatment of pulmonary embolismFirst-in-human studyPreprocedural computed tomography angiographyCatheter-directed embolectomyRight ventricle/left ventricleSecondary safety outcomesVARC-2 criteriaSerious adverse eventsDays post-procedureSingle-arm studyRisk of mortalityPrimary efficacyVARC-2Embolectomy devicesHours postprocedure
2022
Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.
Jagielak D, Targonski R, Frerker C, Abdel-Wahab M, Wilde J, Werner N, Lauterbach M, Leick J, Grygier M, Misterski M, Erglis A, Narbute I, Witkowski AR, Adam M, Frank D, Gatto F, Schmidt T, Lansky AJ. Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial. EuroIntervention 2022, 18: 590-597. PMID: 35608032, PMCID: PMC10241272, DOI: 10.4244/eij-d-22-00238.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve implantationAortic valve implantationLesion volumeValve implantationTechnical successC trialSingle lesionCerebral embolic protection devicesPerformance endpointBrain diffusion-weighted magnetic resonance imagingLarge single lesionsPrimary safety endpointBrain lesion volumeDiffusion-weighted magnetic resonance imagingCerebral protection systemSingle-arm studyEmbolic protection devicesPrimary performance endpointRate of deathMagnetic resonance imagingTAVI casesTAVI patientsVARC-2Cerebrovascular eventsPrimary endpoint
2021
Safety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion revascularization: Primary results of the Teleflex Chronic Total Occlusion Study
Kandzari DE, Alaswad K, Jaffer FA, Brilakis E, Croce K, Kearney K, Spaedy A, Yeh R, Thompson C, Nicholson W, Wyman RM, Riley R, Lansky A, Buller C, Karmpaliotis D. Safety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion revascularization: Primary results of the Teleflex Chronic Total Occlusion Study. Catheterization And Cardiovascular Interventions 2021, 99: 263-270. PMID: 34582080, DOI: 10.1002/ccd.29962.Peer-Reviewed Original ResearchConceptsMyocardial infarctionGuidewire recanalizationProcedural successCatheter extensionChronic total coronary occlusion revascularizationChronic total occlusion (CTO) percutaneous revascularizationFavorable procedural successGuide catheter extensionHigher lesion complexityHospital cardiac deathProspective registration studyTotal Occlusion StudyTarget lesion revascularizationPrevalence of diabetesPrior myocardial infarctionSingle-arm studyTIMI grade 2Femoral arterial accessJ-CTO scorePrevious bypass surgeryNon-CTO PCIHospital MACELesion revascularizationCTO revascularizationHemodynamic instability
2019
Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study
Laird JR, Zeller T, Holden A, Scheinert D, Moore E, Mendes R, Schmiedel R, Settlage R, Lansky A, Jaff MR, Investigators B, Elmasri F, Robinson W, Beasley R, Mego D, Marica S, Bersin R, Kujath S, Razavi M, Teßarek J, Schulte K. Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study. Journal Of Vascular And Interventional Radiology 2019, 30: 836-844.e1. PMID: 30956077, DOI: 10.1016/j.jvir.2018.12.031.Peer-Reviewed Original ResearchConceptsMajor adverse eventsWalking Impairment QuestionnaireQuality of lifeLesion revascularizationPrimary patencyMyocardial infarctionIliac artery occlusive diseaseComposite endpoint rateProcedure-related deathsTarget lesion revascularizationArtery occlusive diseaseSingle-arm studyMajor amputationRutherford categoryOcclusive lesionsPrimary endpointSecondary endpointsAdverse eventsClinical improvementImpairment QuestionnaireOcclusive diseaseClinical outcomesMulticenter studyEndpoint rateIliac artery
2010
Mesh covered stent in ST-segment elevation myocardial infarction.
Dudek D, Dziewierz A, Rzeszutko Ł, Legutko J, Dobrowolski W, Rakowski T, Bartus S, Dragan J, Klecha A, Lansky AJ, Siudak Z, Zmudka K. Mesh covered stent in ST-segment elevation myocardial infarction. EuroIntervention 2010, 6: 582-9. PMID: 21044911, DOI: 10.4244/eijv6i5a98.Peer-Reviewed Original ResearchConceptsST-segment elevation myocardial infarctionPercutaneous coronary interventionElevation myocardial infarctionDistal embolisationMyocardial infarctionTotal major adverse cardiac events rateFinal TIMI grade 3 flowMajor adverse cardiac event ratesAdverse cardiac event ratesMyocardial blush grade 3Primary percutaneous coronary interventionTIMI grade 3 flowCardiac event rateGrade 3 flowSingle-arm studySTEMI patientsCoronary interventionThrombus aspirationArm studyStent implantationClinical endpointsGrade 3PatientsClinical feasibilityEvent rates
2007
Six-Month Clinical and Angiographic Results of a Dedicated Drug-Eluting Stent for the Treatment of Coronary Bifurcation Narrowings
Grube E, Buellesfeld L, Neumann FJ, Verheye S, Abizaid A, McClean D, Mueller R, Lansky A, Mehran R, Costa R, Gerckens U, Trauthen B, Fitzgerald PJ. Six-Month Clinical and Angiographic Results of a Dedicated Drug-Eluting Stent for the Treatment of Coronary Bifurcation Narrowings. The American Journal Of Cardiology 2007, 99: 1691-1697. PMID: 17560877, DOI: 10.1016/j.amjcard.2007.01.043.Peer-Reviewed Original ResearchConceptsCoronary bifurcation lesionsBifurcation lesionsDe novo coronary bifurcation lesionsProspective multicenter single-arm studyBiolimus A9-eluting stentMulticenter single-arm studyResult of restenosisTarget lesion revascularizationClinical complication rateSingle-arm studyStent late lossSide branchesDrug-eluting stentsLate stent thrombosisBalloon angioplasty treatmentLesion revascularizationNonbifurcation lesionsAntiplatelet therapyComplication rateAngiographic resultsStent thrombosisBalloon angioplastyPercutaneous interventionAngioplasty treatmentAXXESS stent