Journal of Vascular Surgery
Volume 50, Issue 6 , Pages 1462-1473.e3 , December 2009

Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia

Presented at the Annual Meeting of the Society for Vascular Surgery, Denver, CO, Jun 11-14, 2009.

  • Michael S. Conte, MD

      Affiliations

    • Division of Vascular and Endovascular Surgery, University of California, San Francisco, Calif
    • Corresponding Author InformationReprint requests: Michael S. Conte, MD, Division of Vascular and Endovascular Surgery, University of California San Francisco, 400 Parnassus Avenue, A-581, San Francisco, CA 94143-0222
    • ,
  • Patrick J. Geraghty, MD

      Affiliations

    • Department of Surgery, Washington University School of Medicine, St. Louis, Mo
    • ,
  • Andrew W. Bradbury, MD

      Affiliations

    • Department of Vascular Surgery, Birmingham University, Heart of England NHS Trust, Birmingham, United Kingdom
    • ,
  • Nathanael D. Hevelone, MPH

      Affiliations

    • Division of Vascular and Endovascular, Surgery University of California, San Francisco, Calif
    • ,
  • Stuart R. Lipsitz, ScD

      Affiliations

    • Division of Surgery, Brigham and Women's Hospital, Boston, Mass
    • ,
  • Gregory L. Moneta, MD

      Affiliations

    • Department of Surgery, Division of Vascular Surgery, Oregon Health and Science University, Portland, Ore
    • ,
  • Mark R. Nehler, MD

      Affiliations

    • Division of Vascular Surgery, University of Colorado Denver, Aurora, Colo
    • ,
  • Richard J. Powell, MD

      Affiliations

    • Department of Surgery (Vascular Surgery), Dartmouth Medical School, Hanover, NH
    • ,
  • Anton N. Sidawy, MD

      Affiliations

    • Department of Surgery, Washington VA Medical Center, Washington, DC

Received 14 September 2009 ,Accepted 23 September 2009.

References 

  1. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5–S67
  2. Chen E, Sapirstein W, Ahn C, Swain J, Zuckerman B. FDA perspective on clinical trial design for cardiovascular devices. Ann Thorac Surg. 2006;82:773–775
  3. Grunkemeier GL, Jin R, Starr A. Prosthetic heart valves: Objective Performance Criteria versus randomized clinical trial. Ann Thorac Surg. 2006;82:776–780
  4. Goode J, Sapirstein W, Zuckerman B. FDA perspective on clinical trial design for femoropopliteal stent correction of peripheral vascular insufficiency cardiovascular devices. Catheter Cardiovasc Interv. 2007;69:920–921
  5. Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G VIVA Physicians, Inc.. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007;69:910–919
  6. Geraghty PJ, Matsumura JS, Conte MS. Premarket assessment of devices for treatment of critical limb ischemia: the role of Objective Performance Criteria and Goals. J Vasc Surg. 2009;50:1459–1461
  7. Conte MS, Bandyk DF, Clowes AW, Moneta GL, Seely L, Lorenz TJ, et al. Results of PREVENT III: a multicenter, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery. J Vasc Surg. 2006;43:742–751
  8. Brass EP, Anthony R, Dormandy J, Hiatt WR, Jiao J, Nakanishi A, et al. Circulase Investigators Parenteral therapy with lipo-ecraprost, a lipid-based formulation of a PGE1 analog, does not alter six-month outcomes in patients with critical leg ischemia. J Vasc Surg. 2006;43:752–759
  9. Nehler MR, Brass EP, Anthony R, Dormandy J, Jiao J, McNamara TO, et al. Adjunctive parenteral therapy with lipo-ecraprost, a prostaglandin E1 analog, in patients with critical limb ischemia undergoing distal revascularization does not improve 6-month outcomes. J Vasc Surg. 2007;45:953–960discussion 960-1
  10. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al. BASIL trial participants Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005;366:1925–1934
  11. Bradbury A, Wilmink T, Lee AJ, Bell J, Prescott R, Gillespie I, et al. Bypass versus angioplasty to treat severe limb ischemia: factors that affect treatment preferences of UK surgeons and interventional radiologists. J Vasc Surg. 2004;39:1026–1032
  12. Powell RJ, Dormandy J, Simons M, Morishita R, Annex BH. Therapeutic angiogenesis for critical limb ischemia: design of the hepatocyte growth factor therapeutic angiogenesis clinical trial. Vasc Med. 2004;9:193–198
  13. Powell RJ, Simons M, Mendelsohn FO, Daniel G, Henry TD, Koga M, et al. Results of a double-blind, placebo-controlled study to assess the safety of intramuscular injection of hepatocyte growth factor plasmid to improve limb perfusion in patients with critical limb ischemia. Circulation. 2008;118:58–65
  14. Conte MS, Lorenz TJ, Bandyk DF, Clowes AW, Moneta GL, Seely BL. Design and rationale of the PREVENT III clinical trial: edifoligide for the prevention of infrainguinal vein graft failure. Vasc Endovascular Surg. 2005;39:15–23
  15. Schanzer A, Hevelone N, Owens CD, Belkin M, Bandyk DF, Clowes AW, et al. Technical factors affecting autogenous vein graft failure: observations from a large multicenter trial. J Vasc Surg. 2007;46:1180–1190discussion 1190
  16. Lam RC, Shah S, Faries PL, McKinsey JF, Kent KC, Morrissey NJ. Incidence and clinical significance of distal embolization during percutaneous interventions involving the superficial femoral artery. J Vasc Surg. 2007;46:1155–1159
  17. Shammas NW, Dippel EJ, Coiner D, Shammas GA, Jerin M, Kumar A. Preventing lower extremity distal embolization using embolic filter protection: results of the PROTECT registry. J Endovasc Ther. 2008;15:270–276
  18. Laird JR, Zeller T, Gray BH, Scheinert D, Vranic M, Reiser C, et al. Limb salvage following laser-assisted angioplasty for critical limb ischemia: results of the LACI multicenter trial. J Endovasc Ther. 2006;13:1–11
  19. Bosiers M, Deloose K, Verbist J, Peeters P. Nitinol stenting for treatment of “below-the-knee” critical limb ischemia: 1-year angiographic outcome after Xpert stent implantation. J Cardiovasc Surg (Torino). 2007;48:455–461
  20. Giles KA, Pomposelli FB, Hamdan AD, Blattman SB, Panossian H, Schermerhorn ML. Infrapopliteal angioplasty for critical limb ischemia: relation of TransAtlantic InterSociety Consensus class to outcome in 176 limbs. J Vasc Surg. 2008;48:128–136
  21. Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26:517–538
  22. Diehm N, Baumgartner I, Jaff M, Do DD, Minar E, Schmidli J, et al. A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries. Eur Heart J. 2007;28:798–805

 Competition of interest: Patrick Geraghty is a consultant for WL Gore and Cook Medical; Richard Powell is a consultant for AnGes, Inc.

 Additional material for this article may be found online at www.jvascsurg.org.

 The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest.

PII: S0741-5214(09)01934-X

doi: 10.1016/j.jvs.2009.09.044

Journal of Vascular Surgery
Volume 50, Issue 6 , Pages 1462-1473.e3 , December 2009

Article Tools

* Image Usage & Resolution