2017
Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial
Laird JR, Zeller T, Loewe C, Chamberlin J, Begg R, Schneider PA, Nanjundappa A, Bunch F, Schultz S, Harlin S, Lansky A, Jaff MR. Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial. Journal Of Endovascular Therapy 2017, 25: 68-78. PMID: 29285955, DOI: 10.1177/1526602817749242.Peer-Reviewed Original ResearchConceptsTarget lesion revascularizationMajor adverse eventsProximal popliteal arteryPrimary patencyPopliteal arteryStent fractureAnkle/brachial indexPrimary safety endpointPrimary efficacy endpointTreatment of lesionsQuality of lifeSame time pointsLesion revascularizationRutherford categoryEfficacy endpointSafety endpointSecondary endpointsAdverse eventsBrachial indexSuperficial femoralProcedure successFracture ratesClinical successControl groupArtery
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
2015
Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.
Baumbach A, Mullen M, Brickman AM, Aggarwal SK, Pietras CG, Forrest JK, Hildick-Smith D, Meller SM, Gambone L, den Heijer P, Margolis P, Voros S, Lansky AJ. Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study. EuroIntervention 2015, 11: 75-84. PMID: 25868876, DOI: 10.4244/eijy15m04_01.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAlloysAortic ValveAortic Valve StenosisBrain IschemiaBrazilCardiac CatheterizationCognitionCognition DisordersDiffusion Magnetic Resonance ImagingEmbolic Protection DevicesEuropeFemaleHeart Valve ProsthesisHeart Valve Prosthesis ImplantationHumansIntracranial EmbolismMalePredictive Value of TestsProspective StudiesProsthesis DesignRisk FactorsSeverity of Illness IndexStrokeTime FactorsTreatment OutcomeUltrasonography, Doppler, TranscranialConceptsTranscatheter aortic valve replacementAortic valve replacementValve replacementNew cerebral ischemic lesionsCerebral diffusion-weighted magnetic resonance imagingCerebral ischemic lesionsDays post procedurePrimary safety endpointDiffusion-weighted magnetic resonance imagingMajor cerebral arteriesTotal lesion volumeMagnetic resonance imagingSafety endpointIschemic lesionsTAVR proceduresCerebral arteryCerebral circulationConsecutive subjectsPost procedureAortic archHistorical controlsLesion volumeResonance imagingDW-MRIPatients
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
2012
Nitinol Stent Implantation vs. Balloon Angioplasty for Lesions in the Superficial Femoral and Proximal Popliteal Arteries of Patients With Claudication: Three-Year Follow-up From the RESILIENT Randomized Trial
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Cao AY, Jaff MR. Nitinol Stent Implantation vs. Balloon Angioplasty for Lesions in the Superficial Femoral and Proximal Popliteal Arteries of Patients With Claudication: Three-Year Follow-up From the RESILIENT Randomized Trial. Journal Of Endovascular Therapy 2012, 19: 1-9. PMID: 22313193, DOI: 10.1583/11-3627.1.Peer-Reviewed Original ResearchMeSH KeywordsAgedAlloysAngioplasty, BalloonArterial Occlusive DiseasesChi-Square DistributionConstriction, PathologicEuropeFemaleFemoral ArteryHumansIntermittent ClaudicationKaplan-Meier EstimateMaleMiddle AgedPopliteal ArteryPredictive Value of TestsProsthesis DesignRadiographyRisk AssessmentRisk FactorsStentsTime FactorsTreatment OutcomeUltrasonography, Doppler, DuplexUnited StatesVascular PatencyConceptsTarget lesion revascularizationBalloon angioplastyAngioplasty groupStent groupProximal popliteal artery lesionsGood long-term resultsNitinol stent implantationProximal popliteal arteryMajor adverse eventsLong-term resultsPopliteal artery lesionsShort-term patencyStent fracture rateThree-year followLesion revascularizationPrimary nitinolWithdrew consentIntermittent claudicationAdverse eventsArtery lesionsFemoropopliteal lesionsMulticenter trialPopliteal arteryPrimary implantationSuperficial femoral
2010
Nitinol Stent Implantation Versus Balloon Angioplasty for Lesions in the Superficial Femoral Artery and Proximal Popliteal Artery
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR. Nitinol Stent Implantation Versus Balloon Angioplasty for Lesions in the Superficial Femoral Artery and Proximal Popliteal Artery. Circulation Cardiovascular Interventions 2010, 3: 267-276. PMID: 20484101, DOI: 10.1161/circinterventions.109.903468.Peer-Reviewed Original ResearchConceptsSuperficial femoral arteryProximal popliteal arteryTarget lesion revascularizationAngioplasty groupStent groupFemoral arteryLesion revascularizationPopliteal arteryBalloon angioplastyPrimary patencyAngiographic resultsBetter acute angiographic resultsProvisional stent implantationSuboptimal angiographic resultsEndovascular treatment strategiesFlow-limiting dissectionPercutaneous transluminal angioplastyAcute angiographic resultsTotal lesion lengthLoss of patencySuperficial femoral artery (SFA) stentingSelf-expanding nitinolBailout stentingIntermittent claudicationPrimary stenting
2007
Nonrandomized Comparison of Coronary Stenting Under Intravascular Ultrasound Guidance of Direct Stenting Without Predilation Versus Conventional Predilation With a Semi-Compliant Balloon Versus Predilation With a New Scoring Balloon
de Ribamar Costa J, Mintz GS, Carlier SG, Mehran R, Teirstein P, Sano K, Liu X, Lui J, Na Y, Castellanos C, Biro S, Dani L, Rinker J, Moussa I, Dangas G, Lansky AJ, Kreps EM, Collins M, Stone GW, Moses JW, Leon MB. Nonrandomized Comparison of Coronary Stenting Under Intravascular Ultrasound Guidance of Direct Stenting Without Predilation Versus Conventional Predilation With a Semi-Compliant Balloon Versus Predilation With a New Scoring Balloon. The American Journal Of Cardiology 2007, 100: 812-817. PMID: 17719325, DOI: 10.1016/j.amjcard.2007.03.100.Peer-Reviewed Original ResearchConceptsIntravascular ultrasound guidanceMinimum stent areaStent expansionDirect stentingStent areaUltrasound guidanceStent diameterConsecutive de novo lesionsFinal minimum stent areaDrug-eluting stent eraDe novo lesionsReference vessel sizeSemi-compliant balloonMinimum stent diameterNovo lesionsCoronary stentingStent eraNonrandomized studyNonrandomized comparisonLesion preparationFinal stent expansionScoring balloonPredilationLesion morphologyDES expansion
2006
Drug-Eluting and Bare Nitinol Stents for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery: Long-Term Results from the SIROCCO Trial
Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-Eluting and Bare Nitinol Stents for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery: Long-Term Results from the SIROCCO Trial. Journal Of Endovascular Therapy 2006, 13: 701-710. PMID: 17154704, DOI: 10.1583/05-1704.1.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlloysAngioplasty, BalloonAnti-Bacterial AgentsAtherosclerosisBlood Vessel Prosthesis ImplantationCoated Materials, BiocompatibleDouble-Blind MethodDrug CarriersFemaleFemoral ArteryHumansKaplan-Meier EstimateMaleMiddle AgedProspective StudiesProsthesis FailureRecurrenceSafetySirolimusStentsTreatment OutcomeConceptsChronic limb ischemiaAnkle-brachial indexBare stent groupRestenosis rateSirolimus groupLimb ischemiaStent groupSuperficial femoral artery occlusionType C lesionsDouble-blinded studySymptoms of claudicationBare nitinol stentsMajority of patientsSuperficial femoral arteryFemoral artery occlusionStent restenosis rateNitinol self-expanding stentsSelf-expanding stentsTypes of stentsTVR ratesTLR rateArtery occlusionC lesionsClinical outcomesDrug-Eluting
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
2002
Sirolimus-Eluting Stents for the Treatment of Obstructive Superficial Femoral Artery Disease
Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A, Wiesinger B, Hak JB, Tielemans H, Ziemer G, Cristea E, Lansky A, Bérégi J. Sirolimus-Eluting Stents for the Treatment of Obstructive Superficial Femoral Artery Disease. Circulation 2002, 106: 1505-1509. PMID: 12234956, DOI: 10.1161/01.cir.0000029746.10018.36.Peer-Reviewed Original ResearchConceptsMean percent diameter stenosisSirolimus-eluting stent groupSerious adverse eventsFemoral artery occlusionPercent diameter stenosisStent groupArtery occlusionAdverse eventsArtery diseaseDiameter stenosisSuperficial femoral artery diseaseSuperficial femoral artery obstructionPoor long-term outcomesSuperficial femoral artery occlusionChronic limb ischemiaFemoral artery diseaseFemoral artery obstructionSuccessful guidewire passageUncoated-stent groupPrimary end pointFemoropopliteal artery diseaseLong-term outcomesSirolimus-eluting stentsMean lumen diameterNitinol self-expanding stents
2000
The PARAGON stent study: a randomized trial of a new martensitic nitinol stent versus the Palmaz-Schatz stent for treatment of complex native coronary arterial lesions
Holmes D, Lansky A, Kuntz R, Bell M, Buchbinder M, Fortuna R, O’Shaughnessy C, Popma J, Investigators F. The PARAGON stent study: a randomized trial of a new martensitic nitinol stent versus the Palmaz-Schatz stent for treatment of complex native coronary arterial lesions. The American Journal Of Cardiology 2000, 86: 1073-1079. PMID: 11074202, DOI: 10.1016/s0002-9149(00)01162-0.Peer-Reviewed Original ResearchConceptsStent minimal lumen diameterTarget vessel failureMinimal lumen diameterAngiographic restenosisPalmaz-SchatzLumen diameterPS stentEnd pointSignificant differencesAverage stent lengthBinary angiographic restenosisInfrequent adverse eventsPrimary end pointSecondary end pointsSmaller reference vesselsCoronary arterial lesionsNative coronary lesionsPrior bypass surgeryLong-term outcomesPalmaz-Schatz stentsPrior restenosisLesion revascularizationPercutaneous revascularizationBypass surgeryClinical restenosis