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GORE® VIABAHN® Endoprosthesis Resource Guide


  1. Saxon RR, Chervu A, Jones PA, et al.Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) Trial.  Journal of Vascular & Interventional Radiology2013;24(2):165-173.
  2. Lammer J, Zeller T, Hausegger KA, et al.  Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease).  Journal of the American College of Cardiology 2013;62(15):1320-1327.
  3. Lensvelt MM, Fritschy WM, van Oostayen JA, Holewijn S, Zeebregts CJ, Reijnen MM.  Results of heparin-bonded ePTFE-covered stents for chronic occlusive superficial femoral artery disease.  Journal of Vascular Surgery2012;56(1):118-125.
  4. Zeller T, Peeters P, Bosiers M, et al..  Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm Trial.  Journal of Endovascular Therapy 2014;21(6):765-774.
  5. McQuade K, Gable D, Pearl G, Theune B, Black S. Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. Journal of Vascular Surgery 2010;52(3):584-591.
  6. Saxon RR, Dake MD, Volgelzang RL, Katzen BT, Becker GJ.  Randomized, multicenter study comparing expanded polytetrafluoroethylene-covered endoprosthesis placement with percutaneous transluminal angioplasty in the treatment of superficial femoral artery occlusive disease.  Journal of Vascular & Interventional Radiology2008;19(6):823-832.
  7. Saxon RR, Coffman JM, Gooding JM, Ponec DJ.  Long-term patency and clinical outcome of the Viabahn stent-graft for femoropopliteal artery obstructions.  Journal of Vascular & Interventional Radiology 2007;18(11):1341-1350.
  8. Geraghty PJ, Mewissen MW, Jaff MR, Ansel GM; VIBRANT Investigators.  Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease.  Journal of Vascular Surgery 2013;58(2):386-395.e4.
  9. Schillinger M, Sabeti S, Loewe C, et al..  Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery.  New England Journal of Medicine 2006;354(18):1879-1888.
  10. Laird JR, Katzen BT, Scheinert D, et al.; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circulation: Cardiovascular Interventions 2010;3(3):267-276.
  11. Zeller T, Tiefenbacher C, Steinkamp HJ.  Nitinol stent implantation in TASC A and B superficial femoral artery lesions: the Femoral Artery Conformexx Trial (FACT).  Journal of Endovascular Therapy 2008;15(4):390-398.
  12. Matsumura J; DURABILITY II Investigators. Durability II. Full data set at 12 months. Presented at the International Symposium on Endovascular Therapy (ISET); January 15-19, 2012; Miami Beach, FL.
  13. Krankenberg H, Schlüter M, Steinkamp HJ, et al..  Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST).Circulation 2007;116(3):285-292.
  14. Dake MD, Ansel GM, Jaff MR, et al.; Zilver PTX Investigators.  Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circulation: Cardiovascular Interventions 2011;4(5):495-504.
  15. Dick P, Wallner H, Sabeti S.  Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions.  Catheterization & Cardiovascular Interventions 2009;74(7):1090-1095.
  16. Duda SH; SUPER-SL Investigators.  The SUPER-SL Study. Multi-center, head-to-head comparison of the S.M.A.R.T.® CONTROL Nitinol Stent (Cordis ®) with the Luminexx 6F Stent (Bard ®) for the treatment of long TASC C & D superficial  femoral artery lesions.  Presented at the Leipzig Interventional Course (LINC); January 13-17, 2009; Leipzig, Germany.
  17. Lammer J, Dake MD, Bleyn J, et al..  Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent graft.  Radiology 2000;217(1):95-104.
  18. Medtronic Complete™ SE Vascular Stent System [Instructions for Use]. Minneapolis, MN: Medtronic; 2013. M729425B001 Rev. 1B.
  19. Bosiers M, Deloose K, Callaert J. et al. Less invasive interventions: how feasible is the low-profile approach? 4EVER study-final results.  Presented at the Leipzig Interventional Course (LINC); January 23-26, 2013; Leipzig, Germany.
  20. Cordis S.M.A.R.T. ®  CONTROL ® Stent [Instructions for Use].  Miami Lakes, FL: Cordis; 2013.  100000000922.2.
  21. Soukas PA. The Supera Vasculomimetic Stent in SFA disease. Presented at the New Cardiovascular Horizons 14th Annual Conference (NCVH); June 5-7, 2013; New Orleans, LA.
  22. Lammer J, Bosiers M, Zeller T, et al..  First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease.  Journal of Vascular Surgery 2011;54(2):394-401.
  23. Dake MD, Scheinert D, Tepe G,et al.; Zilver PTX Single-Arm Study Investigators.  Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study.  Journal of Endovascular Therapy2011;18(5):613-623.
  24. Yokoi H; On behalf of the Investigators.  Zilver PTX ® post-market surveillance study of Paclitaxel-eluting stents for treating femoropopliteal artery disease in Japan: 12-month results. Presented at the LINC Asia-Pacific Meeting; March 9-11, 2014; Lantau Island, Hong Kong.
  25. Medtronic Complete™ SE Vascular Stent System [Instructions for Use]. Minneapolis, MN: Medtronic; 2013. M729425B001 Rev. 1B.
  26. Cordis S.M.A.R.T.®  CONTROL ® Stent [Instructions for Use].  Miami Lakes, FL: Cordis; 2013.  100000000922.2.
  27. Ohki T, Angle JF, Yokoi H, Jaff M, Popma J.   Effectiveness of the Misago stent for the treatment of superficial femoral artery disease: 12-month results of the First Japan and the United States Collaboration Trial (OSPREY).  Presented at the Transcatheter Cardiovascular Therapeutics Twenty-Sixth Annual Symposium Transcatheter Cardiovascular Therapeutics (TCT); September 13-17, 2014; Washington, DC.  Journal of the American College of Cardiology 2014;64(11):B155.  TCT-530.
  28. Tepe G, Laird J, Schneider P, et al.; IN.PACT SFA Trial Investigators. 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.
  29. DeFord J.  Lutonix TM Drug Coated Balloon Device for the Treatment of Femoropopliteal Artery Disease.  CR Bard, Inc.  FDA Executive Summary Prepared for the June 12, 2014 meeting of the Circulatory System Devices Advisory Panel.  Published June 12, 2014.  Accessed April 6, 2015.
  30. McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA; DEFINITIVE LE Investigators.  Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study.  JACC: Cardiovascular Interventions 2014;7(8):923-933.
  31. Dave RM, Patlola R, Kollmeyer K, et al.; CELLO Investigators.  Excimer laser recanalization of femoropopliteal lesions and 1-year patency: results of the CELLO registry.   Journal of Endovascular Therapy 2009;16(6):665-675.
  32. Zeller T, Krankenberg H, Steinkamp H, et al.   One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial.   Journal of Endovascular Therapy 2009;16(6):653-662.
  33. Tepe G.  What is the impact of extensive lesion calcification on the outcome of DEB treatment?  A core lab analysis in 91 patients.  Presented at the 41st Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (VEITHsymposium); November 18-22, 2014; New York, NY.
  34. Supera® Peripheral Stent System [Instructions for Use].  Webster, TX: IDEV Technologies, Inc; 2014.
  35. Schönefeld E, Torsello G, Osada N, Herten M, Bisdas T, Donas KP. Long-term outcome of femoropopliteal stenting. Results of a prospective study.  Journal of Cardiovascular Surgery 2013;54(5):617-623.
  36. Bosiers M, Deloose K, Callaert J, et al.   Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial.  Journal of Endovascular Therapy 2015;22(1):1-10.
  37. Krankenberg H; on behalf of the FAIR Trial Investigators.  DCB and ISR: Insights from the FAIR Study.  Presented at the Leipzig Interventional Course (LINC); January 27-29, 2015; Leipzig, Germany.
  38. Dippel EJ; EXCITE ISR Investigators.  EXCITE ISR: initial results.  Presented at the Transcatheter Cardiovascular Therapeutics Twenty-Sixth Annual Symposium Transcatheter Cardiovascular Therapeutics (TCT); September 13-17, 2014; Washington, DC.
  39. W. L. Gore & Associates, Inc. GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis (REVISE). Bethesda, MD: National Library of Medicine; 2014. Published August 15, 2008. Updated October 14, 2014. Accessed April 1, 2015.  NLM Identifier: NCT00737672.
  40. Mohr BA, Sheen A, Rodriguez A, Vesely T.  Economic evaluation of the Viabahn Stent-Graft vs. angioplasty for hemodialysis graft stenosis: evidence from the REVISE Clinical Trial.   Presented at the 40th Annual Society of Interventional Radiology (SIR) Annual Scientific Meeting; February 28- March 5, 2015; Atlanta, GA. Abstract 16.
  41. Vogel PM, Parise C.  SMART stent for salvage of hemodialysis access grafts.  Journal of Vascular & Interventional Radiology 2004;15(10):1051-1060.
  42. Vogel PM, Parise C.  Comparison of SMART stent placement for arteriovenous graft salvage versus successful graft PTA.  Journal of Vascular & Interventional Radiology 2005;16(12):1619-1626.
  43. Liang HL, Pan HB, Lin YH, et al. Metallic stent placement in hemodialysis graft patients after insufficient balloon dilation. Korean Journal of Radiology 2006;7(2):118-124.
  44. Maya ID, Allon M. Outcomes of thrombosed arteriovenous grafts: comparison of stents vs angioplasty. Kidney International 2006;69(5):934-937.
  45. Chan MR, Bedi RJ, et al.  Stent placement versus angioplasty improves patency of arteriovenous grafts and blood flow of arteriovenous fistulae.  Clinical Journal of the American Society of Nephrology 2008;3(3):699-705.
  46. Hatakeyama S, Toikawa T, Okamoto A, et al.  Efficacy of SMART stent placement for salvage angioplasty in hemodialysis patients with recurrent vascular access stenosis.  International Journal of Nephrology2011;2011:464735.
  47. Kim CY, Tandberg DJ, Rosenberg MD, Miller MJ, Suhocki PV, Smith TP.  Outcomes of prosthetic hemodialysis grafts after deployment of bare metal versus covered stents at the venous anastomosis.  Cardiovascular & Interventional Radiology 2012;35(4):832-838.
  48. Vesely TM, Siegel JB.  Use of the peripheral cutting balloon to treat hemodialysis-related stenoses.  Journal of Vascular & Interventional Radiology 2005;16(12):1593-1603.
  49. Haskal ZJ, Trerotola S, Dolmatch B, et al.  Stent graft versus balloon angioplasty for failing dialysis-access grafts. New England Journal of Medicine 2010;362(6):494-503.
  50. Funaki B, Slaby J. Covered stent compression in dialysis access. Seminars in Interventional Radiology2011;28(1):128-130.
  51. Quevedo HC, Arain SA, Ali G, Abi Rafeh N.  A critical view of the peripheral atherectomy data in the treatment of infrainguinal arterial disease.  Journal of Invasive Cardiology 2014;26(1):22-29.
  52. Bard Peripheral Vascular, Inc. Fluency ® Plus Endovascular Stent Graft.  Expand Your Reach.  [Product Brochure].  Tempe, AZ: Bard Peripheral Vascular, Inc; 2014.
  53. Flair ® Endovascular Stent Graft [Instructions for Use].  Tempe, AZ: C. R. Bard, Inc; 2012.  B05659 Vers.1/07-12.
  54. Fluency ® Plus Endovascular Stent Graft [Instructions for Use].  Tempe, AZ: Bard Peripheral Vascular, Inc; 2014.  B05667 Rev.4/05-14.
  55. Laird JR. Randomized controlled trials I: new insights from INPACT SFA I-II. Presented at the Transcatheter Cardiovascular Therapeutics Twenty-Sixth Annual Symposium Transcatheter Cardiovascular Therapeutics (TCT); September 13-17, 2014; Washington, DC.
  56. Medtronic Vascular, Inc. IN.PACT ® Admiral ® Paclitaxel-coated PTA Balloon Catheter. [Product Brochure]. Santa Rosa, CA: Medtronic Vascular, Inc; 2014. UC201502574EN.
  57. Lutonix ® 035 Drug Coated Balloon PTA Catheter [Instructions for Use]. New Hope, MN: Lutonix, Inc; 2015. DW5200-01 Rev 01.
  58. Zilver ® Drug-Eluting Peripheral Stent [Instructions for Use]. Limerick, Ireland: Cook Ireland, LTD; 2014. IFU0093-4.
  59. GORE ® VIABAHN ® Endoprosthesis with Heparin Bioactive Surface [Instructions for Use]. W. L. Gore & Associates, Inc; 2014. 20022838.
  60. Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC: Cardiovascular Interventions 2014;7(1):10-19.
  61. Micari A, Cioppa A, Vadalà G, et al. Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. JACC: Cardiovascular Interventions 2012;5(3):331-338.
  62. Yoon YC, Shin BS, Ahn M, Park MH, Ohm JY, Kim HJ. Comparison of a nitinol stent versus balloon angioplasty for treatment of a dysfunctional arteriovenous graft.  Journal of the Korean Society of Radiology 2012;66(6):519-526.
  63. Keeling WB, Shames ML, Stone PA, et al. Plaque excision with the Silverhawk catheter: early results in patients with claudication or critical limb ischemia. Journal of Vascular Surgery 2007;45(1):25–31.
  64. Singh N, Sidawy AN, DeZee KJ, Neville RF, Akbari C, Henderson W. Factors associated with early failure of infrainguinal lower extremity arterial bypass. Journal of Vascular Surgery 2008;47(3):556–561.
  65. Duda SH, Bosiers M, Lammer J, et al. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. Journal of Vascular & Interventional Radiology 2005;16(3):331–338.
  66. Kedora J, Hohmann S, Garrett W, Munschaur C, Theune B, Gable D. Randomized comparison of percutaneous Viabahn stent-grafts versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease. Journal of Vascular Surgery 2007;45(1):10–16.
  67. Alimi YS, Hakam Z, Hartung O, et al.Efficacy of Viabahn® in the treatment of severe superficial femoral artery lesions: which factors influence long-term patency? European Journal of Vascular & Endovascular Surgery2008;35(3):346–352.
  68. Lensvelt MMA, Golchehr B, Kruse RR, Holewijn S, van Walraven LA, Fritschy WM, Zeebregts, CJ & Reijnen, MMPJ. The outcome of failed endografts inserted for superficial femoral artery occlusive disease. Journal of Vascular Surgery 2013;57(2):415-420.
  69. W. L. Gore & Associates.  Multi-center study for stent graft system for peripheral artery (VJH 11-01).  Bethesda, MD: National Library of Medicine; 2012.  Available from:  NLM Identifier: NCT01575808.  Published April 9, 2012.  Updated June 9, 2015.  Accessed May 10, 2016.
  70. Bajwa T, Chopra P, Coats R, et al. Endovascular repair of the superficial femoral artery. Endovascular Today 2008;7(9) Supplement:1–23.
  71. Cheng CC, Silva MB Jr. Techniques for achieving long-term secondary patency. Endovascular Today 2012;11(8) Supplement:10–14.
  72. Micari A, Vadalà G, Castriota F, et al. 1-year results of paclitaxel-coated balloons for long femoropopliteal artery disease: evidence from the SFA-long study.  JACC: Cardiovascular Interventions 2016;9(9):950-956.
  73. Müller-Hülsbeck S, Keirse K, Zeller T, Schroë H, Diaz-Cartelle J.  Twelve-month results from the MAJESTIC Trial of the Eluvia paclitaxel-eluting stent for treatment of obstructive femoropopliteal disease.  Journal of Endovascular Therapy.  In press.