Literature

OPG:

Conte, MC et al. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia.
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Geraghty, PJ et al. Premarket assessment of devices for treatment of critical limb ischemia: The role of Objective Performance Criteria and Goals.
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Kumar, A et al. FDA perspective on objective performance goals and clinical trial design for evaluating catherer-based treatment of critical limb ischemia.
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BASIL:
Adam, DJ et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. The Lancet 2005. Dec 3;366(9501):1925-34.
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Circulase:
Brass, EP et al. 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. Journal of Vascular Surgery 2005
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Nehler, MR 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. Journal of Vascular Surgery, 2006.
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PREVENT III:
Conte MS, Lorenz T, Bandyk DF, Clowes AW, Moneta GL, Seely L. Design and rationale of the PREVENT III clinical trial: edifoligide for the prevention of infrainguinal vein graft failure. Vascular and Endovascular Surgery 2005; 39:15-23.
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Conte MS, Bandyk DF, Clowes AW, Moneta GL, Namini H, Seely L. Risk factors, medical therapies and perioperative events in limb salvage surgery: observations from the PREVENT III multi-center trial. J Vasc Surg 2005; 42:456-465.
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Conte MS, Bandyk DF, Clowes AW, Moneta GL, Seely L, Hamdan AD, Roddy SP, Belkin M, Berceli SA, DeMasi RJ, Samson RH, Berman SS for the PREVENT III Investigators. Results of PREVENT III: a multi-center, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery. J Vasc Surg 2005; 43:742-751.
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Nguyen LL, Lipsitz SR, Bandyk DF, Clowes AW, Moneta GL, Belkin M, Conte MS. Resource utilization in the treatment of critical limb ischemia: the effect of tissue loss, comorbidities, and graft-related events. J Vasc Surg 2006;44:971-6.
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Nguyen LL, Moneta GL, Conte MS, Bandyk DF, Clowes AW, Seely BL, Hamdan AD, Roddy SP, Belkin M, Berceli SA, DeMasi RJ, Samson RH, Berman SS. Prospective multi-center study of quality of life before and after lower extremity vein bypass in 1404 patients with critical limb ischemia. J Vasc Surg 2006;44:977-84.
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Berceli SA, Hevelone N, Lipsits S, Bandyk DF, Clowes AW, Moneta GL, Conte MS. Surgical and endovascular revision of infrainguinal vein bypass grafts: analysis of midterm outcomes from the PREVENT III trial. J Vasc Surg 2007; 46:1173-9.
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Nguyen LL, Brahmanandam S, Bandyk DF, Belkin M, Clowes AW, Moneta GL, Conte MS. Female gender and oral anticoagulants are associated with wound complications in lower extremity vein bypass: an analysis of 1404 operations for critical limb ischemia. J Vasc Surg 2007; 46:1191-7.
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Schanzer A, Hevelone N, Owens CD, Belkin M, Bandyk DF, Clowes AW, Moneta GL, Conte MS. Technical factors affecting autogenous vein graft failure: observations from a large multi-center trial. J Vasc Surg 2007; 46:1180-90.
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Schanzer A, Hevelone N, Owens CD, Beckman JA, Belkin M, Conte MS. Statins are independently associated with reduced mortality in patients undergoing infrainguinal bypass surgery for critical limb ischemia. J Vasc Surg 2008;47:774-81.
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Schanzer AS, Mega J, Meadows J, Samson RH, Bandyk DF, Conte MS. Risk-stratification in critical limb ischemia: derivation and validation of a simplified model to predict amputation-free survival using multi-center surgical outcomes data. J Vasc Surg (in press)
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Nguyen LL, Hevelone N, Rogers SO, Bandyk DF, Clowes AW, Moneta GL, Lipsitz S, Conte MS. Disparity in outcomes of surgical revascularization for limb salvage: race and gender are synergistic determinants of vein graft failure and limb loss. Circulation (submitted)
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