2024
Novel Mechanical Aspiration Thrombectomy in Patients With Acute Pulmonary Embolism: Results From the Prospective APEX-AV Trial
Ranade M, Foster M, Brady P, Sokol S, Butty S, Klein A, Maholic R, Safar A, Patel T, Zlotnick D, Gans D, Pollak J, Ferrera D, Stegman B, Basra S, Moriarty J, Keeling B, Investigators A. Novel Mechanical Aspiration Thrombectomy in Patients With Acute Pulmonary Embolism: Results From the Prospective APEX-AV Trial. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 4: 102463. PMID: 40061412, PMCID: PMC11887559, DOI: 10.1016/j.jscai.2024.102463.Peer-Reviewed Original ResearchAcute intermediate-risk PEMechanical aspiration thrombectomyIntermediate-risk PEPulmonary embolismAspiration thrombectomyRV/LV ratioClot burdenAdverse eventsMm HgLow rate of adverse eventsMean pulmonary artery pressureEnd pointsRate of adverse eventsAcute pulmonary embolismPulmonary artery pressureSafety end pointDevice-related deathsTreat pulmonary embolismSingle-arm studyEffectiveness end pointAccess site bleedingStatistically significant reductionCardiac injuryClinical deteriorationArterial pressureMedical Devices Applying for Outpatient Medicare Supplemental Payments
Moneer O, Johnston J, Rathi V, Ross J, Dhruva S. Medical Devices Applying for Outpatient Medicare Supplemental Payments. JAMA Health Forum 2024, 5: e244016. PMID: 39546305, PMCID: PMC11568453, DOI: 10.1001/jamahealthforum.2024.4016.Peer-Reviewed Original ResearchConceptsCenters for Medicare & Medicaid ServicesMedicare beneficiariesUS Centers for Medicare & Medicaid ServicesCross-sectional studyCross-sectional analysisPatient demographic characteristicsClinical decision-makingMedicaid ServicesMain OutcomesHispanic patientsClinical evidence requirementsPremarket clinical studyOutpatient settingOutpatient paymentsTraditional pathwaysMedicareSupplemental paymentsFiscal yearTransitional pass-through paymentsReimbursementDemographic dataEffectiveness end pointPathway applicationClinical studiesAuthorization pathwaysEquity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study
McEntegart M, Gonzalo N, Fendelander L, West N, Lansky A. Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 102289. PMID: 39649816, PMCID: PMC11624350, DOI: 10.1016/j.jscai.2024.102289.Peer-Reviewed Original ResearchCoronary artery diseaseCalcified coronary artery diseasePercutaneous coronary interventionTarget lesion failureCoronary intravascular lithotripsyArtery diseaseFemale patientsIntravascular lithotripsySubcohort analysis of patientsPrevalence of coronary artery calcificationEnd pointsOptical coherence tomography imagesComposite of cardiac deathClinical events committeeSafety end pointAnalysis of patientsIndependent core laboratoryIncreased risk of mortalityIschemia-driven target lesion revascularizationTarget vessel myocardial infarctionTarget lesion revascularizationCoronary artery calcificationEffectiveness end pointCAD studiesCardiology clinical trials
2023
Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry
Dexter D, Kado H, Shaikh A, Schor J, Annambhotla S, Zybulewski A, Paulisin J, Bisharat M, Mouawad N, Bunte M, Maldonado T, Skripochnik E, Raskin A, Gandhi S, Ichinose E, Beasley R, Mojibian H, Investigators C. Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry. Journal Of The Society For Cardiovascular Angiography & Interventions 2023, 2: 100585. PMID: 39129803, PMCID: PMC11308834, DOI: 10.1016/j.jscai.2023.100585.Peer-Reviewed Original ResearchDeep vein thrombosisLower extremity deep vein thrombosisProximal lower extremity deep vein thrombosisPrimary effectiveness end pointExtremity deep vein thrombosisEffectiveness end pointSerious adverse eventsClotTriever systemAdverse eventsMechanical thrombectomyDevice-related serious adverse eventsHistory of DVTEnd pointIntensive care unit monitoringPercutaneous mechanical thrombectomyProcedural blood lossIndependent core laboratorySelf-reported painBilateral thrombiComer patientsMarder scoreHospital outcomesSymptom durationThrombus burdenMost patientsPredicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months
Johnson M, Spies J, Scott K, Kato B, Mu X, Rectenwald J, White R, Lewandowski R, Khaja M, Zuckerman D, Casciani T, Gillespie D. Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. Journal Of Vascular And Interventional Radiology 2023, 34: 517-528.e6. PMID: 36841633, DOI: 10.1016/j.jvir.2022.12.009.Peer-Reviewed Original ResearchConceptsVena cava filtersEnd pointCava filtersPrimary effectiveness end pointPrimary safety end pointInferior vena cava filterEffectiveness end pointSafety end pointVenous thromboembolic eventsProphylactic placementAnticoagulation therapyThromboembolic eventsVenous thromboembolismThrombotic occlusionNonrandomized studyPrimary safetyTomography scanLower incidenceSignificant PESite investigatorsPatientsCore laboratoryStrut perforationMonthsDVTPredicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months
Johnson M, Spies J, Scott K, Kato B, Mu X, Rectenwald J, White R, Lewandowski R, Khaja M, Zuckerman D, Casciani T, Gillespie D. Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. Journal Of Vascular Surgery Venous And Lymphatic Disorders 2023, 11: 573-585.e6. PMID: 36872169, DOI: 10.1016/j.jvsv.2022.11.002.Peer-Reviewed Original ResearchConceptsVena cava filtersEnd pointCava filtersPrimary effectiveness end pointPrimary safety end pointInferior vena cava filterEffectiveness end pointSafety end pointVenous thromboembolic eventsProphylactic placementAnticoagulation therapyThromboembolic eventsVenous thromboembolismThrombotic occlusionNonrandomized studyPrimary safetyTomography scanLower incidenceSignificant PESite investigatorsPatientsCore laboratoryStrut perforationMonthsDVT
2022
Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity
Maldonado TS, Dexter DJ, Kado H, Schor J, Annambhotla S, Mojibian H, Beasley RE, Investigators C. Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity. Journal Of Vascular Surgery Venous And Lymphatic Disorders 2022, 10: 1251-1259. PMID: 35714903, DOI: 10.1016/j.jvsv.2022.04.015.Peer-Reviewed Original ResearchConceptsDeep vein thrombosisLower extremity deep vein thrombosisExtremity deep vein thrombosisComplete thrombus removalSymptom durationThrombus removalChronic thrombusOutcomes RegistryClotTriever systemPatients' durationThrombus morphologyPrimary effectiveness end pointEffectiveness end pointPatient symptom durationIndependent core laboratorySingle-session procedureComer patientsMarder scoreSubacute thrombusAcute thrombusVein thrombosisChronic subgroupProcedural characteristicsThrombusChronicityInterim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry
Dexter DJ, Kado H, Schor J, Annambhotla S, Olivieri B, Mojibian H, Maldonado TS, Gandhi S, Paulisin J, Bunte MC, Angel W, Roberts J, Veerina K, Abramowitz S, Elmasri F, Hnath J, Jung M, Long D, Sanchez L, Cosme O, Skripochnik E, Lodha A, Shaikh A, King C, Bisharat M, Beasley RE, Investigators C. Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry. Journal Of Vascular Surgery Venous And Lymphatic Disorders 2022, 10: 832-840.e2. PMID: 35218955, DOI: 10.1016/j.jvsv.2022.02.013.Peer-Reviewed Original ResearchConceptsDeep vein thrombosisLower extremity deep vein thrombosisPrimary effectiveness end pointExtremity deep vein thrombosisEffectiveness end pointSerious adverse eventsComer patientsVein thrombosisAdverse eventsClinical outcomesDevice-related serious adverse eventsBilateral deep vein thrombosisVenous Clinical Severity ScoreNumeric Pain Rating ScaleEnd pointComplete thrombus removalPost-thrombotic syndromeClinical severity scorePain rating scaleQuality of lifeClotTriever systemMarder scoreClinical improvementSymptom durationMechanical thrombectomy
2018
Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention: A Randomized Clinical Trial
Nogueira R, Frei D, Kirmani J, Zaidat O, Lopes D, Turk A, Heck D, Mason B, Haussen D, Levy E, Mehta S, Lazzaro M, Chen M, Dörfler A, Yoo A, Derdeyn C, Schwamm L, Langer D, Siddiqui A. Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention: A Randomized Clinical Trial. JAMA Neurology 2018, 75: 304-311. PMID: 29296999, PMCID: PMC5885851, DOI: 10.1001/jamaneurol.2017.3967.Peer-Reviewed Original ResearchConceptsAcute ischemic strokeSerious adverse eventsProcedure-related serious adverse eventsStent retrieverMechanical thrombectomy devicesAspiration groupAdverse eventsEnd pointClinical trialsThrombectomy devicesLarge vessel acute ischemic strokeDevice-related serious adverse eventsScale scoreHealth Stroke Scale scoreMedian baseline NIHSS scorePrimary effectiveness end pointPrimary safety end pointAcute ischemic stroke interventionCerebral infarction (TICI) gradeEffectiveness end pointBaseline NIHSS scorePrimary end pointSafety end pointStroke Scale scoreHours of onset
2017
Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease
Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C, Jaff MR, Holden AH, Lyden SP, Mewissen M, Katzen B, Nanjundappa A, Khuddus M, Ricci J, Fry D, Shishehbor M, Bosarge C, Kovach R, Goodwin M, Raja M, Mayeda G, Sandhu J, Rosales O, Crowder W, Paolini D, Henretta J, Desai P, Farhat N, Kang E, Ansel G, Ghani M, Miller W, Pollock C, Korngold E, Angle J, Schultz G, Gensler T, Lopez L, Park J, Al-Khoury G, Joels C, Metzger C. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease. Circulation 2017, 136: 1102-1113. PMID: 28729250, PMCID: PMC5598919, DOI: 10.1161/circulationaha.117.028893.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, BalloonCardiovascular AgentsCoated Materials, BiocompatibleFemaleFemoral ArteryHalf-LifeHumansKaplan-Meier EstimateMaleMiddle AgedPaclitaxelPeripheral Arterial DiseaseProspective StudiesSeverity of Illness IndexSingle-Blind MethodTime FactorsTreatment OutcomeVascular PatencyConceptsDrug-coated balloonsPrimary safety end pointSafety end pointTarget lesion revascularizationLesion revascularizationPrimary patencyEnd pointFemoropopliteal diseaseClinical outcomesPivotal studiesDifferent drug-coated balloonsPrimary effectiveness end pointStellarex drug-coated balloonTarget limb major amputationEffectiveness end pointAnkle-brachial indexProcedure-related deathsFemoropopliteal artery diseasePrimary patency rateDrug-Coated BalloonKaplan-Meier estimatesPaclitaxel plasma concentrationsQuality of lifeDCB cohortMajor amputationClinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014
Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014. Otolaryngology 2017, 156: 285-288. PMID: 28093943, DOI: 10.1177/0194599816684094.Peer-Reviewed Original ResearchConceptsPostapproval studiesPivotal studiesUS FoodPrimary effectiveness end pointAvailable FDA documentsEffectiveness end pointPivotal clinical studiesBenefit-risk assessmentCross-sectional analysisPremarket evidenceMedian durationClinical evidenceDrug Administration premarket approvalsOtolaryngologic diseaseMedian enrollmentClinical studiesHigh-risk medical devicesDrug AdministrationEnd pointHigh-risk devicesFDA documentsOne-thirdTwo-thirdsPremarket approvalFDA
2015
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarket
2007
Clinical End Points in Coronary Stent Trials
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Gabriel Steg P, Morel M, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Clinical End Points in Coronary Stent Trials. Circulation 2007, 115: 2344-2351. PMID: 17470709, DOI: 10.1161/circulationaha.106.685313.Peer-Reviewed Original ResearchConceptsEnd point definitionsAcademic Research ConsortiumClinical end pointsEnd pointDrug AdministrationConsensus criteriaEffectiveness end pointClinical trial programKey pathophysiological mechanismMost clinical trialsCoronary stent trialsClinical trial purposesEvaluation of safetyTiming of assessmentResearch ConsortiumAssessment of deathStent thrombosisPathophysiological mechanismsAcademic research organizationsStent trialsMyocardial infarctionClinical trialsConsensus recommendationsTrial programPoint definition
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply