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 postprocedureLB-8 | First in Human Safety and Feasibility of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (The ENGULF Trial)
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. LB-8 | First in Human Safety and Feasibility of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (The ENGULF Trial). Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 101877. DOI: 10.1016/j.jscai.2024.101877.Peer-Reviewed Original ResearchTreatment of pulmonary embolismPulmonary embolism
2016
Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter
Stavropoulos SW, Chen JX, Sing RF, Elmasri F, Silver MJ, Powell A, Lynch FC, Aal A, Lansky A, Muhs BE, Investigators F. Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter. Journal Of Vascular And Interventional Radiology 2016, 27: 1531-1538.e1. PMID: 27569678, DOI: 10.1016/j.jvir.2016.06.028.Peer-Reviewed Original ResearchConceptsDeep vein thrombosisInferior vena cava filterPulmonary embolismVena cava filtersFilter placementFilter retrievalIVC filtersCava filtersSymptomatic recurrent pulmonary embolismRate of PERetrievable inferior vena cava filtersFilter-related complicationsLobar pulmonary embolismProspective multicenter trialRecurrent pulmonary embolismLow complication rateSubsegmental pulmonary embolismFilter dwell timeTemporary indicationsPrimary endpointSecondary endpointsComplication rateVein thrombosisCaval filtrationMulticenter trial
2014
The DENALI Trial: An Interim Analysis of a Prospective, Multicenter Study of the Denali Retrievable Inferior Vena Cava Filter
Stavropoulos SW, Sing RF, Elmasri F, Silver MJ, Powell A, Lynch FC, Aal AK, Lansky AJ, Settlage RA, Muhs BE, Investigators D. The DENALI Trial: An Interim Analysis of a Prospective, Multicenter Study of the Denali Retrievable Inferior Vena Cava Filter. Journal Of Vascular And Interventional Radiology 2014, 25: 1497-1505.e1. PMID: 25066514, DOI: 10.1016/j.jvir.2014.07.001.Peer-Reviewed Original ResearchConceptsInferior vena cava filterRetrievable inferior vena cava filtersTechnical success ratePulmonary embolismVena cava filtersFilter placementIVC filtersCava filtersClinical successFilter retrievalPrimary study endpointRecurrent pulmonary embolismDeep vein thrombosisMulticenter clinical studyRetrievable IVC filtersSuccess ratePresent interim reportTemporary indicationsCaval interruptionVein thrombosisStudy endpointFilter fractureMulticenter studyFilter implantationClinical studies