Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease
Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C, Jaff MR, Holden AH, Lyden SP, Mewissen M, Katzen B, Nanjundappa A, Khuddus M, Ricci J, Fry D, Shishehbor M, Bosarge C, Kovach R, Goodwin M, Raja M, Mayeda G, Sandhu J, Rosales O, Crowder W, Paolini D, Henretta J, Desai P, Farhat N, Kang E, Ansel G, Ghani M, Miller W, Pollock C, Korngold E, Angle J, Schultz G, Gensler T, Lopez L, Park J, Al-Khoury G, Joels C, Metzger C. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease. Circulation 2017, 136: 1102-1113. PMID: 28729250, PMCID: PMC5598919, DOI: 10.1161/circulationaha.117.028893.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, BalloonCardiovascular AgentsCoated Materials, BiocompatibleFemaleFemoral ArteryHalf-LifeHumansKaplan-Meier EstimateMaleMiddle AgedPaclitaxelPeripheral Arterial DiseaseProspective StudiesSeverity of Illness IndexSingle-Blind MethodTime FactorsTreatment OutcomeVascular PatencyConceptsDrug-coated balloonsPrimary safety end pointSafety end pointTarget lesion revascularizationLesion revascularizationPrimary patencyEnd pointFemoropopliteal diseaseClinical outcomesPivotal studiesDifferent drug-coated balloonsPrimary effectiveness end pointStellarex drug-coated balloonTarget limb major amputationEffectiveness end pointAnkle-brachial indexProcedure-related deathsFemoropopliteal artery diseasePrimary patency rateDrug-Coated BalloonKaplan-Meier estimatesPaclitaxel plasma concentrationsQuality of lifeDCB cohortMajor amputation