2024
Results of SurVeil Versus IN.PACT Admiral Paclitaxel Coated Balloons in Femoropopliteal Arteries: Outcomes of the Randomised TRANSCEND Study Through 24 Months
Brodmann M, Gray W, Schneider P, Kurzmann-Guetl K, Schweiger L, Zeller T, Thieme M, Kilaru S, Bachinsky W, Feldman R, Holden A, Varcoe R, Lansky A, Rosenfield K, Investigators T. Results of SurVeil Versus IN.PACT Admiral Paclitaxel Coated Balloons in Femoropopliteal Arteries: Outcomes of the Randomised TRANSCEND Study Through 24 Months. European Journal Of Vascular And Endovascular Surgery 2024 PMID: 39615582, DOI: 10.1016/j.ejvs.2024.11.351.Peer-Reviewed Original ResearchFemoropopliteal artery diseasePrimary safetyPrimary patencyTRANSCEND studiesNon-inferiorityArtery diseaseRutherford stage 2Procedure related deathNon-inferiority clinical studyTarget lesion revascularisationTarget vessel revascularisationPaclitaxel coated balloonTarget limb amputationPrimary efficacyEfficacy endpointBinary restenosisClinical studiesFemoropopliteal arteriesSecondary outcomesRelated deathsCoated balloonsPatientsMonthsEfficacyPatency
2023
Percutaneous Transluminal Angioplasty for Infrapopliteal Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-analysis of Primary Patency and Binary Restenosis Rates.
Snyder D, Zilinyi R, Pruthi S, George S, Tirziu D, Lansky A, Mintz A, Sethi S, Parikh S. Percutaneous Transluminal Angioplasty for Infrapopliteal Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-analysis of Primary Patency and Binary Restenosis Rates. Journal Of Endovascular Therapy 2023, 15266028231212133. PMID: 38008929, DOI: 10.1177/15266028231212133.Peer-Reviewed Original ResearchChronic limb-threatening ischemiaPercutaneous transluminal angioplastyBinary restenosis ratePrimary patencyPrimary patency rateBinary restenosisTransluminal angioplastyRestenosis rateFuture RCTsPatency ratesTrial dataChronic limb threatening ischemiaLimb threatening ischemiaLimb-threatening ischemiaRandom-effects modelMeta-analysis demonstrateIntermittent claudicationEndovascular therapyCochrane CENTRALPower calculationMeta-analysis estimatesControl armPatencyRCTsSystematic reviewChocolate 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 statusProspective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis
Dolmatch B, Cabrera T, Pergola P, Balamuthusamy S, Makris A, Cooper R, Moore E, Licht J, Macaulay E, Maleux G, Pfammatter T, Settlage R, Cristea E, Lansky A, Investigators A, Dolmatch B, Goh G, Hawkins S, Macaulay E, Spark I, de Graff R, Deutschmann H, Kickuth R, Maleux G, Pfammatter T, Kirksey L, Mendes R, Aruny J, Ali V, Cabrera T, Pergola P, Sharma D, Moore E, Shah H, Dwyer A, Yee D, Teng W, Cooper R, Balamuthusamy S, Lipkowitz G, Saad T, Licht J, Makris A, Rogers T, Burgess J, Hoggard J. Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis. Kidney International 2023, 104: 189-200. PMID: 36990214, DOI: 10.1016/j.kint.2023.03.015.Peer-Reviewed Original ResearchConceptsTarget lesion primary patencyAccess circuit primary patencyPercutaneous transluminal angioplastyTarget lesion reinterventionPrimary patencyTransluminal angioplastyArteriovenous fistulaAVF stenosisAdditional clinical outcomesCircuit primary patencyCovered stent groupLesion primary patencyMulticenter clinical studyHemodialysis arteriovenous fistula stenosisArteriovenous fistula stenosisHemodialysis patientsPrimary outcomeRandomized studyClinical outcomesAVF dysfunctionStent groupClinical studiesFistula stenosisSix monthsPatients
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
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 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
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