2023
Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study.
Böhme T, Zeller T, Shishehbor M, Werner M, Brodmann M, Parise H, Holden A, Lichtenberg M, Parikh S, Kashyap V, Pietras C, Tirziu D, Beschorner U, Krishnan P, Niazi K, Wali A, Lansky A. Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study. Journal Of Endovascular Therapy 2023, 15266028231179589. PMID: 37314243, DOI: 10.1177/15266028231179589.Peer-Reviewed Original ResearchLutonix drug-coated balloonDrug-coated balloonsPrimary safety endpointDM statusFemoropopliteal diseaseDiabetes mellitusSafety endpointFemoropopliteal lesionsSimilar safetyHigh-risk patient populationFemoropopliteal artery lesionsIschemic rest painNon-DM patientsSymptomatic femoropopliteal lesionsPrimary efficacy endpointMajor adverse eventsTherapy of choiceDrug-Coated BalloonMajor amputationRest painEfficacy endpointPrimary patencyAdverse eventsArtery lesionsDiabetes status
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
Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II
Nazif TM, Moses J, Sharma R, Dhoble A, Rovin J, Brown D, Horwitz P, Makkar R, Stoler R, Forrest J, Messé S, Dickerman S, Brennan J, Zivadinov R, Dwyer MG, Lansky AJ, Investigators R. Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II. JACC Cardiovascular Interventions 2021, 14: 515-527. PMID: 33663779, DOI: 10.1016/j.jcin.2020.11.011.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementSafety endpointValve replacementProcedure-related ischemic strokeCerebral embolic protectionComposite efficacy endpointPrimary safety endpointCerebral embolizationCerebral protectionEfficacy endpointII trialCerebral injuryIschemic strokeEmbolic protectionPatientsDrug AdministrationUS sitesU.S. FoodEndpointData reviewTrialsMulticenterEmbolizationInjury
2018
Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II
Brodmann M, Werner M, Holden A, Tepe G, Scheinert D, Schwindt A, Wolf F, Jaff M, Lansky A, Zeller T. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Catheterization And Cardiovascular Interventions 2018, 93: 335-342. PMID: 30474206, DOI: 10.1002/ccd.27943.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overEuropeFemaleFemoral ArteryHumansLithotripsyMaleMiddle AgedNew ZealandPeripheral Arterial DiseasePopliteal ArteryProgression-Free SurvivalProspective StudiesRetreatmentRisk FactorsSeverity of Illness IndexTime FactorsUltrasonic TherapyVascular CalcificationVascular PatencyConceptsMajor adverse eventsIntravascular lithotripsyPrimary patencyDuplex ultrasonographyPAD IIAcute procedure successFinal residual stenosisPrimary effectiveness endpointPrimary safety endpointKey secondary endpointPeripheral arterial stenosisMulti-center studySonic pressure wavesMechanism of actionCompelling safetyEffectiveness endpointAnti-proliferative therapiesSafety endpointSecondary endpointsVascular complicationsAdverse eventsFemoropopliteal lesionsResidual stenosisPrimary outcomeAcute gain
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
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
2002
Localized intracoronary beta radiation therapy to inhibit recurrence of in-stent restenosis
Waksman R, Raizner A, Yeung A, Lansky A, Vandertie L, on behalf of the INHIBIT Investigators. Localized intracoronary beta radiation therapy to inhibit recurrence of in-stent restenosis. Clinical Research In Cardiology 2002, 91: 40-41. DOI: 10.1007/s00392-002-1307-z.Peer-Reviewed Original ResearchTarget lesion revascularizationMajor adverse cardiac eventsPrimary safety endpointTarget vessel revascularizationLesion revascularizationStent restenosisMyocardial infarctionSafety endpointRestenosis rateRadiated groupLong lesionsRadiation therapyBinary angiographic restenosis rateIntracoronary beta-radiation therapyBeta-radiation therapyIntracoronary beta radiationSuccessful coronary interventionAdverse cardiac eventsAngiographic restenosis ratePrimary efficacy endpointIntracoronary radiation therapyRecurrence of restenosisCentering catheterOverall revascularizationEfficacy endpointUse of localised intracoronary β radiation in treatment of in-stent restenosis: the INHIBIT randomised controlled trial
Waksman R, Raizner AE, Yeung AC, Lansky AJ, Vandertie L, investigators I. Use of localised intracoronary β radiation in treatment of in-stent restenosis: the INHIBIT randomised controlled trial. The Lancet 2002, 359: 551-557. PMID: 11867107, DOI: 10.1016/s0140-6736(02)07741-3.Peer-Reviewed Original ResearchConceptsBinary angiographic restenosis ratePrimary safety endpointAngiographic restenosis rateTarget lesion revascularisationStent restenosisPlacebo groupSafety endpointRestenosis rateRadiated groupMyocardial infarctionMajor adverse cardiac eventsIntracoronary beta radiationIntracoronary β-radiationSuccessful coronary interventionAdverse cardiac eventsPrimary efficacy endpointRecurrence of restenosisBeta-radiation treatmentEfficacy endpointAngiographic outcomesCardiac eventsCoronary interventionIntracoronary stentingProcedural successVascular brachytherapy