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
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
2019
Balloon-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
A 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