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
Clinical outcome after interventions with paclitaxel-coated balloons: a PCR statement.
Lansky A, Cremonesi A, Scheller B, James S, Grubman D, Fajadet J, Sauguet A, Micari A, Sarno G, Bosiers M, Baumbach A, Wijns W. Clinical outcome after interventions with paclitaxel-coated balloons: a PCR statement. EuroIntervention 2020, 15: 1225-1227. PMID: 32044731, DOI: 10.4244/eijv15i14a220.Peer-Reviewed Original Research
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 2DissectionLesionsBalloonStenosisPatencyPatients
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 groupArtery
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
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
2004
Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results.
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 JP. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Journal Of Invasive Cardiology 2004, 16 Suppl A: 15a-19a. PMID: 23573600.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 diseaseSix-month resultsLong-term outcomesSirolimus-eluting stentsMean lumen diameter
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
2001
Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices
Dangas G, Mehran R, Kokolis S, Feldman D, Satler L, Pichard A, Kent K, Lansky A, Stone G, Leon M. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. Journal Of The American College Of Cardiology 2001, 38: 638-641. PMID: 11527609, DOI: 10.1016/s0735-1097(01)01449-8.Peer-Reviewed Original ResearchConceptsPercutaneous coronary interventionArteriotomy closure devicesManual compressionVascular complicationsCoronary interventionClosure deviceHigher vascular complication ratesVascular complication ratesVascular surgical repairPrevious clinical studiesAchievement of hemostasisHematocrit dropEarly ambulationComplication rateConsecutive patientsTransfemoral approachSheath removalSurgical repairArteriovenous fistulaHemostasis techniquesAccess siteClinical studiesLarge cohortMultivariate analysisComplicationsIntravascular Radiation Therapy after Balloon Angioplasty of Narrowed Femoropopliteal Arteries to Prevent Restenosis: Results of the PARIS Feasibility Clinical Trial
Waksman R, Laird J, Jurkovitz C, Lansky A, Gerrits F, Kosinski A, Murrah N, Weintraub W, Investigators F. Intravascular Radiation Therapy after Balloon Angioplasty of Narrowed Femoropopliteal Arteries to Prevent Restenosis: Results of the PARIS Feasibility Clinical Trial. Journal Of Vascular And Interventional Radiology 2001, 12: 915-921. PMID: 11487671, DOI: 10.1016/s1051-0443(07)61569-3.Peer-Reviewed Original ResearchConceptsPercutaneous transluminal angioplastyAnkle-brachial indexRadiation therapySFA lesionsRestenosis rateBalloon angioplastyAngiographic binary restenosis rateMean reference vessel diameterSuccessful percutaneous transluminal angioplastySuperficial femoral artery lesionsClinical restenosis rateFeasibility clinical trialBinary restenosis rateClinical adverse eventsReference vessel diameterFemoral artery lesionsMean lesion lengthRate gamma radiationIntravascular radiation therapyMicroSelectron-HDR afterloaderGamma radiation therapyRutherford scoreAdverse eventsArtery lesionsClinical improvement