2022
Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study)
Shishehbor MH, Zeller T, Werner M, Brodmann M, Parise H, Holden A, Lichtenberg M, Parikh SA, Kashyap VS, Pietras C, Tirziu D, Ardakani S, Beschorner U, Krishnan P, Niazi KA, Wali AU, Lansky AJ. Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study). Circulation 2022, 145: 1645-1654. PMID: 35377157, DOI: 10.1161/circulationaha.122.059646.Peer-Reviewed Original ResearchConceptsLutonix drug-coated balloonDrug-coated balloonsEnd pointPrimary efficacy end pointPrimary safety end pointIndependent clinical events committeeIschemic rest painPrimary efficacy rateEfficacy end pointPrimary end pointSafety end pointClinical events committeeMajor adverse eventsRate of restenosisDrug-Coated BalloonNoninferiority end pointSafety event rateAverage lesion lengthMajor amputationPopliteal diseaseRest painBailout stentingEfficacy ratePrimary patencyAdverse events
2020
Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study
Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA, Parikh SA, Armstrong EJ, Tepe G, Lansky A, Gray WA. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. Journal Of Endovascular Therapy 2020, 27: 473-480. PMID: 32242768, PMCID: PMC7288854, DOI: 10.1177/1526602820914598.Peer-Reviewed Original ResearchConceptsPeripheral artery diseasePeripheral intravascular lithotripsyIntravascular lithotripsyResidual stenosisAcute gainObservational studyChronic limb-threatening ischemiaSingle-arm observational studyBalloon-based technologiesHigher acute gainMean residual stenosisLimb-threatening ischemiaLower limb arteriesEnd of procedureSevere arterial calcificationLow residual stenosisReal-world studyAngiographic complicationsDistal embolizationHospital dischargeIII studyArtery diseaseThrombotic eventsEndovascular treatmentLimb arteries
2019
Treating Post-Angioplasty Dissection in the Femoropopliteal Arteries Using the Tack Endovascular System 12-Month Results From the TOBA II Study
Gray WA, Cardenas JA, Brodmann M, Werner M, Bernardo NI, George JC, Lansky A. Treating Post-Angioplasty Dissection in the Femoropopliteal Arteries Using the Tack Endovascular System 12-Month Results From the TOBA II Study. JACC Cardiovascular Interventions 2019, 12: 2375-2384. PMID: 31806218, DOI: 10.1016/j.jcin.2019.08.005.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, BalloonBlood Vessel ProsthesisBlood Vessel Prosthesis ImplantationEuropeFemaleFemoral ArteryHumansMaleMiddle AgedPeripheral Arterial DiseasePopliteal ArteryProspective StudiesProsthesis DesignRisk FactorsStentsTime FactorsTreatment OutcomeUnited StatesVascular Access DevicesVascular PatencyVascular System InjuriesConceptsProximal popliteal arteryDrug-coated balloonsSuperficial femoral arteryPlain balloonPopliteal arteryFemoral arteryTack Endovascular SystemLong-term outcomesDCB angioplastyEfficacy endpointPrimary patencyResidual stenosisRestenotic lesionsMulticenter studyFemoropopliteal arteriesEndovascular SystemAngioplastyArteryClassification 2DissectionLesionsBalloonStenosisPatencyPatientsBalloon-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
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 gainA prospective, multi‐center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry
Mustapha JA, Lansky A, Shishehbor M, McClure J, Johnson S, Davis T, Makam P, Crowder W, Konstantino E, Attaran RR, Investigators T. A prospective, multi‐center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry. Catheterization And Cardiovascular Interventions 2018, 91: 1144-1148. PMID: 29513389, DOI: 10.1002/ccd.27565.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, BalloonEquipment DesignFemaleFemoral ArteryHumansMaleMiddle AgedPeripheral Arterial DiseasePopliteal ArteryProduct Surveillance, PostmarketingProspective StudiesRegistriesRisk FactorsStentsTime FactorsTreatment OutcomeUnited StatesVascular Access DevicesVascular PatencyConceptsTarget lesion revascularizationPrimary endpointFemoropopliteal peripheral artery diseaseSymptomatic peripheral arterial diseaseExcellent procedural outcomesLower dissection ratePeripheral arterial diseasePeripheral artery diseaseAcute procedural successLong-term outcomesPost-market registryMulti-center studyAngioplasty balloon catheterPercutaneous transluminal angioplasty balloon catheterRutherford classCause mortalityLesion revascularizationMajor amputationArtery diseaseArterial diseaseProcedural successUnplanned amputationBalloon catheterProcedural outcomesProcedure success
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 groupArterySafety and Performance of Lithoplasty for Treatment of Calcified Peripheral Artery Lesions
Brodmann M, Werner M, Brinton TJ, Illindala U, Lansky A, Jaff MR, Holden A. Safety and Performance of Lithoplasty for Treatment of Calcified Peripheral Artery Lesions. Journal Of The American College Of Cardiology 2017, 70: 908-910. PMID: 28797363, DOI: 10.1016/j.jacc.2017.06.022.Peer-Reviewed Original ResearchHumansPeripheral Arterial DiseaseProspective StudiesTreatment OutcomeUltrasonic TherapyVascular Calcification
2015
Local delivery of paclitaxel in the treatment of peripheral arterial disease
Ng VG, Mena C, Pietras C, Lansky AJ. Local delivery of paclitaxel in the treatment of peripheral arterial disease. European Journal Of Clinical Investigation 2015, 45: 333-345. PMID: 25615282, DOI: 10.1111/eci.12407.Peer-Reviewed Original ResearchConceptsPeripheral artery diseaseEndovascular revascularizationArtery diseaseLocal deliveryClinical studiesLocal drug deliveryPeripheral arterial diseasePeripheral vascular diseasePrimary patency rateSystemic adverse effectsUse of paclitaxelLong-term efficacyDrug-Eluting BalloonDrug-eluting stentsTerms of efficacyBrief exposure periodArterial diseaseBalloon angioplastyPatency ratesVascular diseaseBalloon catheterCoated balloonMEDLINE searchStent failureActive drug