Complex iliac lesions

Consider the challenges of treating complex iliac lesions

  • Multicenter and prospective studies demonstrate suboptimal performance of bare metal stent (BMS) in complex iliac disease1-6 
    • In the COBEST Trial, the five-year primary patency of BMS in TASC II C&D lesions was approximately 25%1
  • Perforation / rupture of the iliac arteries and aortic bifurcation is not uncommon and can be life-threatening7,8
    • In the presence of severe calcification, surgery guidelines recommend stent graft placement for treatment of iliac occlusive disease (IOD)9
angiogram

Before

Flush ostial chronic total occlusion of the right common iliac artery with reconstitution of the proximal common femoral artery

Images courtesy of Barry Weinstock, M.D. Used with permission.

Read the full case study

angiogram

After

Post-placement of 7 x 150 mm  GORE® VIABAHN® Endoprosthesis and 7 x 59 mm balloon expandable covered stent

Images courtesy of Barry Weinstock, M.D. Used with permission.

Read the full case study

Kaplan-meier curve of primary patency for TASC C/ D lesion

The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface* and the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis have been proven to address the treatment challenges in complex IOD.

Demonstrated durability

  • Stent grafts have demonstrated superiority over BMS for treating complex iliac lesions5,6
    • Self-expanding stent grafts, at three years, have demonstrated improved patency over BMS when treating TASC D iliac lesions5 
    • Balloon expandable stent grafts, through five years, have demonstrated higher primary patency compared to BMS1

Proven patency

  • The GORE® VIABAHN® Endoprosthesis family has 12-month patency that approaches published surgical bypass 
    • The GORE® VIABAHN® Endoprosthesis has demonstrated 91% 12-month primary patency10
    • The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis has demonstrated 97% 9-month primary patency11
    • Meta-analysis review of 3733 open bypass patients across 29 studies demonstrated pooled primary patency of 95%8

The breadth of the GORE® VIABAHN® Endoprosthesis self and balloon expandable configurations offers the widest range of lengths and diameters to treat complex iliac disease12,13

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* As used by Gore, PROPATEN Bioactive Surface refers to Gore’s proprietary CBAS Heparin Surface.

  1. Mwipatayi BP, Sharma S, Daneshmand A, et al; COBEST co-investigators.  Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease.  Journal of Vascular Surgery 2016;64(1):83-94.e1.
  2. Mwipatayi BP, Thomas S, Wong J, et al; Covered Versus Balloon Expandable Stent Trial (COBEST) Co-investigators.  A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease.  Journal of Vascular Surgery 2011;54(6):1561-1570. 
  3. Sabri SS, Choudhri A, Orgera G, et al.  Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation.  Journal of Vascular & Interventional Radiology 2010;21(7):995-1003.
  4. Piazza M, Squizzato F, Spolverato G, et al.  Outcomes of polytetrafluoroethylene-covered stent versus bare-metal stent in the primary treatment of severe iliac artery obstructive lesions.  Journal of Vascular Surgery 2015;62(5):1210-1218.e1
  5. Piazza M, Squizzato F, Dall’Antonia A, et al. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185.
  6. Chang RW, Goodney PP, Baek JH, Nolan BW, Rzucidlo EM, Powell RJ. Long-term results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease. Journal of Vascular Surgery 2008;48(2):362-367.
  7. Jongkind V, Akkersdijk GJ, Yeung KK, Wisselink W. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. Journal of Vascular Surgery 2010;52(5):1376-1383. 
  8. Indes JE, Pfaff MJ, Farrokhyar F, et al. Clinical outcomes of 5358 patients undergoing direct open bypass or endovascular treatment for aortoiliac occlusive disease: a systematic review and meta-analysis. Journal of Endovascular Therapy 2013;20(4):443-455. 
  9. Society for Vascular Surgery Lower Extremity Guidelines Writing Group; Conte MS, Pomposelli FB, et al; Society for Vascular Surgery. Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: Management of asymptomatic disease and claudication. Journal of Vascular Surgery 2015;61(3)Supplement: 2S-41S.e1.
  10.   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.
  11.   Bismuth J, Gray BH, Holden A, Metzger C, Panneton J; VBX FLEX Study Investigators. Pivotal study of a next-generation balloon-expandable stent-graft for treatment of iliac occlusive disease. Journal of Endovascular Therapy 2017;24(5):629-637. http://journals.sagepub.com/doi/full/10.1177/1526602817720463
  12.   GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface [Instructions for Use]. Flagstaff, AZ:  W. L. Gore & Associates, Inc; 2014. MD147177.
  13.   GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc 2016. MD148076.

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