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 disease.1-6
    • 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-threatening.7,8
    • 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 II C/D lesion

The GORE® VIABAHN® Endoprosthesis with Heparin 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 lesions.5,6
    • Self-expanding stent grafts, at three years, have demonstrated improved patency over BMS when treating TASC II D iliac lesions.5 
    • Balloon expandable stent grafts, through five years, have demonstrated higher primary patency compared to BMS.1

Proven patency

  • The VIABAHN® Device family has one-year patency that approaches published surgical bypass results. 
    • The VIABAHN® Device has demonstrated 91% one-year primary patency.10
    • The VIABAHN® VBX Stent Graft has demonstrated 94.5% one-year primary patency.11
    • Meta-analysis review of 3,733 open bypass patients across 29 studies demonstrated pooled primary patency of 95%.8

The breadth of the VIABAHN® Device self and balloon expandable configurations offers the widest range of lengths and diameters to treat complex iliac disease.12,13

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

† Also referred to as the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in some regions.

  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.   Panneton JM, Bismuth J, Gray BH, Holden A. Three-year follow-up of patients with iliac occlusive disease treated with the Viabahn Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy 2020;27(5):728-736. https://journals.sagepub.com/ doi/10.1177/1526602820920569
  12.   GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Instructions for Use (IFU). W. L. Gore & Associates, Inc. Accessed February 8, 2023. https://eifu.goremedical.com
  13.   GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc 2016. MD148076.

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

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