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In-stent restenosis of the SFA

Consider the complexity and therapeutic challenge of in-stent restenosis (ISR) in the superficial femoral artery (SFA)

  • ISR is the “Achilles' heel” of peripheral vascular interventions1
    • Reported to occur within a year in up to 40% of femoropopliteal lesions treated with bare-metal stents2-4
  • Lesion length is a risk factor for ISR for bare-metal and drug-eluting stents5-6
  • There are a limited number of multicenter, prospective randomized ISR trials7-10

The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface* delivers exceptional patency for in-stent restenosis lesions.10

Results from the Gore RELINE Clinical Study, a multicenter, prospective, randomized, controlled trial10

Proven patency

  • 75% 12-month primary patency compared to 28% percutaneous transluminal angioplasty (PTA)10
  • Fewer than one third the number of patients required an intervention at 12 months compared to PTA.11 

Demonstrated durability

  • Four times greater primary patency compared to PTA at two years 12
  • More than three times greater freedom from target lesion revascularization (fTLR) compared to PTA at two years11

Fewer Reinterventions

  • Fewer patients had reintervention procedures compared to PTA at two years11

Efficacy in complex lesions and in a difficult patient population

  • The average lesion length in the Gore RELINE Clinical Study exceeded 17 cm10 
  • In the same study, approximately 21% of patients had occlusions10

…[In] my clinical experience, the GORE® VIABAHN® [Endoprosthesis] is an excellent choice for treating long-segment de novo as well as in-stent restenotic occlusions13

-Robert Bersin, MD, Seattle, Washington.

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*Heparin Bioactive Surface is synonymous with the CBAS Heparin Surface.

  1. Adams GL, Bersin RM, George JC, Subramanian V, Soukas PA. Data-driven treatment approach to in-stent restenosis. Endovascular Today 2015;14(6)Supplement:3-8.
  2. Bosiers M, Torsello G, Gissler HM, et al. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. Journal of Endovascular Therapy 2009;16(3):261-269. 
  3. 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. 
  4. 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.
  5. Gao M, Zhao X, Tao Y, et al. Incidence and predictors of in-stent re-stenosis in the superficial femoral artery: evaluation of long-term outcomes by color duplex ultrasound. Ultrasound in Medicine & Biology 2016;42(3):717-726.
  6. Iida O, Takahara M, Soga Y; ZEPHYR Investigators. 3-year results of ZEPHYR (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) registry. Presented at the Leipzig Interventional Course (LINC); January 24-27, 2017; Leipzig, Germany.
  7. Krankenberg H; FAIR Trial Investigators. DCB and ISR: insights from the FAIR Study. Presented at the Leipzig Interventional Course (LINC); January 27-29, 2015; Leipzig, Germany.
  8. Lutonix® 035 Drug Coated Balloon PTA Catheter [Instructions for Use]. New Hope, MN: Lutonix, Inc; 2016. BAW1387400 Rev. 1.
  9. 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.
  10.   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.
  11.   GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2014. MD 147177.
  12.   Bosiers M, Deloose K.  2-year results of the RELINE Trial comparing Viabahn Stent-Grafts to POBA for ISR show durable benefits to endograft treatment.   Presented at the 41st Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (VEITHsymposium); November 18-22, 2014; New York, NY.  Abstract 168. 
  13.   Bersin RM.  Treating ISR with the GORE® VIABAHN® Endoprosthesis after bilateral SFA CTO interventions.  Endovascular Today 2015;14(6)Supplement:13-14. https://evtoday.com/pdfs/et0615_GORE_supplement_viabahn_sec%204.pdf