Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery

Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: Twelve-month results from the BIOLUX P-I randomized trial. J Endovascr Ther. 2015;22(1):14–21. https://doi.org/10.1177/1526602814564383.

Article  Google Scholar 

Tepe G, Gögebakan Ö, Redlich U, Tautenhahn J, Ricke J, Halloul Z, et al. Angiographic and clinical outcomes after treatment of femoro-popliteal lesions with a novel paclitaxel-matrix-coated balloon catheter. CardioVasc Interven Radiol. 2017;40(10):1535–44. https://doi.org/10.1007/s00270-017-1713-2.

Article  Google Scholar 

Schroeder H, Werner M, Meyer DR, Reimer P, Krüger K, Jaff MR, et al. Circulation. 2022;135(23):2227–36.

Article  Google Scholar 

Schroeder H, Meyer DR, Lux B, Ruecker F, Martorana M, Duda S. Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery: Outcomes from the ILLUMENATE first-in-human study. Cathete Cardiovasc. 2015;86(2):278–86. https://doi.org/10.1002/ccd.25900.

Article  Google Scholar 

Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, et al. Stellarex drug-coated balloon for treatment of femoropopliteal disease: Twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation. 2017;136(12):1102–13. https://doi.org/10.1161/CIRCULATIONAHA.117.028893.

CAS  Article  PubMed  PubMed Central  Google Scholar 

Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015;131(5):495–502. https://doi.org/10.1161/CIRCULATIONAHA.114.011004.

CAS  Article  PubMed  PubMed Central  Google Scholar 

Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol. 2015;66:2329–38.

Article  Google Scholar 

Iida O, Soga Y, Urasawa K, Saito S, Jaff MR, Wang H, et al. Drug-coated balloon vs standard percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal arteries: one-year results of the MDT-2113 SFA Japan randomized trial. J Endovasc Ther. 2018;25(1):109–17. https://doi.org/10.1177/1526602817745565.

Article  PubMed  Google Scholar 

Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. New England J Med. 2015;373(2):145–53. https://doi.org/10.1056/NEJMoa1406235.

CAS  Article  Google Scholar 

Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization. JACC Cardiovasc Interv. 2014;7(1):10–9. https://doi.org/10.1016/j.jcin.2013.05.022.

Article  PubMed  Google Scholar 

Thieme M, von Bilderling P, Paetzel C, Karnabatidis D, Perez Delgado J, Lichtenberg M. The 24-month results of the lutonix global SFA registry. JACC: Cardiovasc Interv. 2017. https://doi.org/10.1016/j.jcin.2017.04.041.

Article  Google Scholar 

Micari A, Cioppa A, Vadalà G, Castriota F, Liso A, Marchese A, et al. 2-Year results of paclitaxel-eluting balloons for femoropopliteal artery disease. JACC: Cardiovasc Interv. 2013;6(3):282–9. https://doi.org/10.1016/j.jcin.2013.01.128.

Article  Google Scholar 

Bausback Y, Willfort-Ehringer A, Sievert H, Geist V, Lichtenberg M, del Giudice C, et al. Six-month results from the initial randomized study of the ranger paclitaxel-coated balloon in the femoropopliteal segment. J Endovasc Therapy. 2017;24(4):459–67. https://doi.org/10.1177/1526602817710770.

Article  Google Scholar 

Schmidt A, Piorkowski M, Görner H, Steiner S, Bausback Y, Scheinert S, et al. Drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry. JACC: Cardiovascular Interv. 2016;9:715–24.

Google Scholar 

Zeller T, Rastan A, Macharzina R, Tepe G, Kaspar M, Chavarria J, et al. Drug-coated balloons vs. drug-eluting stents for treatment of long femoropopliteal lesions. J Endovasc Therapy. 2014;21(3):359–68. https://doi.org/10.1583/13-4630MR.1.

Article  Google Scholar 

Lichtenberg M, von Bilderling P, Ranft J, Niemoller K, Grell H, Briner L, et al. Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry. J Cardiovasc Surg. 2017;59(1):45–50.

Article  Google Scholar 

Elmariah S, Ansel GM, Brodmann M, Doros G, Fuller S, Gray WA, et al. Design and rationale of a randomized noninferiority trial to evaluate the SurVeil drug-coated balloon in subjects with stenotic lesions of the femoropopliteal artery — the TRANSCEND study. American Heart J Mosby. 2019;209:88–96.

Article  Google Scholar 

Steiner S, Schmidt A, Zeller T, Tepe G, Thieme M, Maiwald L, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. European Heart J. 2020;41(27):2541–52.

CAS  Article  Google Scholar 

Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: A systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018. https://doi.org/10.1161/JAHA.118.011245.

Article  PubMed  PubMed Central  Google Scholar 

留言 (0)

沒有登入
gif