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Volumn 23, Issue 3, 2010, Pages 129-137

Understanding objective performance goals for critical limb ischemia trials

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CRITICAL ILLNESS; DISEASE SEVERITY; FUNCTIONAL ASSESSMENT; HIGH RISK PATIENT; HUMAN; LEG REVASCULARIZATION; LIMB ISCHEMIA; LIMB MOVEMENT; OUTCOME ASSESSMENT; PATIENT IDENTIFICATION; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT; RISK FACTOR; STUDY DESIGN; SURVIVAL RATE;

EID: 77956327633     PISSN: 08957967     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.semvascsurg.2010.06.001     Document Type: Article
Times cited : (78)

References (21)
  • 1
    • 33846497950 scopus 로고    scopus 로고
    • Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II)
    • Norgren L., Hiatt W.R., Dormandy J.A., Nehler M.R., Harris K.A., Fowkes F.G. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg 2007, 45(suppl S):S5-S67.
    • (2007) J Vasc Surg , vol.45 , Issue.SUPPL. S
    • Norgren, L.1    Hiatt, W.R.2    Dormandy, J.A.3    Nehler, M.R.4    Harris, K.A.5    Fowkes, F.G.6
  • 2
    • 28244470064 scopus 로고    scopus 로고
    • Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial
    • 9501
    • Adam D.J., Beard J.D., Cleveland T., et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005, 366:1925-1934. 9501.
    • (2005) Lancet , vol.366 , pp. 1925-1934
    • Adam, D.J.1    Beard, J.D.2    Cleveland, T.3
  • 3
    • 77951546951 scopus 로고    scopus 로고
    • Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: an intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy
    • Bradbury A.W., Adam D.J., Bell J., et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: an intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy. J Vasc Surg 2010, 51(suppl):5S-17S.
    • (2010) J Vasc Surg , vol.51 , Issue.SUPPL.
    • Bradbury, A.W.1    Adam, D.J.2    Bell, J.3
  • 4
    • 77951533705 scopus 로고    scopus 로고
    • Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: analysis of amputation free and overall survival by treatment received
    • Bradbury A.W., Adam D.J., Bell J., et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: analysis of amputation free and overall survival by treatment received. J Vasc Surg 2010, 51(suppl):18S-31S.
    • (2010) J Vasc Surg , vol.51 , Issue.SUPPL.
    • Bradbury, A.W.1    Adam, D.J.2    Bell, J.3
  • 5
    • 77951645389 scopus 로고    scopus 로고
    • Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) and the (hoped for) dawn of evidence-based treatment for advanced limb ischemia
    • Conte M.S. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) and the (hoped for) dawn of evidence-based treatment for advanced limb ischemia. J Vasc Surg 2010, 51(suppl):69S-75S.
    • (2010) J Vasc Surg , vol.51 , Issue.SUPPL.
    • Conte, M.S.1
  • 6
    • 33747349203 scopus 로고    scopus 로고
    • FDA perspective on clinical trial design for cardiovascular devices
    • 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.
    • (2006) Ann Thorac Surg , vol.82 , pp. 773-775
    • Chen, E.1    Sapirstein, W.2    Ahn, C.3    Swain, J.4    Zuckerman, B.5
  • 7
    • 33747362048 scopus 로고    scopus 로고
    • Prosthetic heart valves: objective performance criteria versus randomized clinical trial
    • Grunkemeier G.L., Jin R., Starr A. Prosthetic heart valves: objective performance criteria versus randomized clinical trial. Ann Thorac Surg 2006, 82:776-780.
    • (2006) Ann Thorac Surg , vol.82 , pp. 776-780
    • Grunkemeier, G.L.1    Jin, R.2    Starr, A.3
  • 8
    • 34249910647 scopus 로고    scopus 로고
    • Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease
    • Rocha-Singh K.J., Jaff M.R., Crabtree T.R., Bloch D.A., Ansel G. 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.
    • (2007) Catheter Cardiovasc Interv , vol.69 , pp. 910-919
    • Rocha-Singh, K.J.1    Jaff, M.R.2    Crabtree, T.R.3    Bloch, D.A.4    Ansel, G.5
  • 9
    • 70649090106 scopus 로고    scopus 로고
    • Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia
    • Conte M.S., Geraghty P.J., Bradbury A.W., et al. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg 2009, 50:1462-1473.
    • (2009) J Vasc Surg , vol.50 , pp. 1462-1473
    • Conte, M.S.1    Geraghty, P.J.2    Bradbury, A.W.3
  • 10
    • 70649097211 scopus 로고    scopus 로고
    • Premarket assessment of devices for treatment of critical limb ischemia: the role of Objective Performance Criteria and Goals
    • Geraghty P.J., Matsumura J.S., Conte M.S. 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.
    • (2009) J Vasc Surg , vol.50 , pp. 1459-1461
    • Geraghty, P.J.1    Matsumura, J.S.2    Conte, M.S.3
  • 11
    • 33645734355 scopus 로고    scopus 로고
    • Results of PREVENT III: a multicenter, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery
    • discussion 751
    • Conte M.S., Bandyk D.F., Clowes A.W., 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. discussion 751.
    • (2006) J Vasc Surg , vol.43 , pp. 742-751
    • Conte, M.S.1    Bandyk, D.F.2    Clowes, A.W.3
  • 12
    • 33645738835 scopus 로고    scopus 로고
    • 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
    • Brass E.P., Anthony R., Dormandy J., 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. J Vasc Surg 2006, 43:752-759.
    • (2006) J Vasc Surg , vol.43 , pp. 752-759
    • Brass, E.P.1    Anthony, R.2    Dormandy, J.3
  • 13
    • 34247337315 scopus 로고    scopus 로고
    • 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
    • discussion 960-951
    • Nehler M.R., Brass E.P., Anthony R., 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, 45:953-960. discussion 960-951.
    • (2007) J Vasc Surg , vol.45 , pp. 953-960
    • Nehler, M.R.1    Brass, E.P.2    Anthony, R.3
  • 14
    • 28244470064 scopus 로고    scopus 로고
    • Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial
    • 9501
    • Adam D.J., Beard J.D., Cleveland T., et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005, 366:1925-1934. 9501.
    • (2005) Lancet , vol.366 , pp. 1925-1934
    • Adam, D.J.1    Beard, J.D.2    Cleveland, T.3
  • 15
    • 50949129278 scopus 로고    scopus 로고
    • 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
    • Powell R.J., Simons M., Mendelsohn F.O., 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.
    • (2008) Circulation , vol.118 , pp. 58-65
    • Powell, R.J.1    Simons, M.2    Mendelsohn, F.O.3
  • 16
    • 37249057873 scopus 로고    scopus 로고
    • Technical factors affecting autogenous vein graft failure: observations from a large multicenter trial
    • discussion 1190
    • Schanzer A., Hevelone N., Owens C.D., et al. Technical factors affecting autogenous vein graft failure: observations from a large multicenter trial. J Vasc Surg 2007, 46:1180-1190. discussion 1190.
    • (2007) J Vasc Surg , vol.46 , pp. 1180-1190
    • Schanzer, A.1    Hevelone, N.2    Owens, C.D.3
  • 17
    • 0030928783 scopus 로고    scopus 로고
    • Recommended standards for reports dealing with lower extremity ischemia: revised version
    • Rutherford R.B., Baker J.D., Ernst C., et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg 1997, 26:517-538.
    • (1997) J Vasc Surg , vol.26 , pp. 517-538
    • Rutherford, R.B.1    Baker, J.D.2    Ernst, C.3
  • 18
    • 34548270780 scopus 로고    scopus 로고
    • A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries
    • Diehm N., Baumgartner I., Jaff M., 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.
    • (2007) Eur Heart J , vol.28 , pp. 798-805
    • Diehm, N.1    Baumgartner, I.2    Jaff, M.3
  • 19
    • 77956326758 scopus 로고    scopus 로고
    • Do objective performance goals (OPGs) for critical limb ischemia (CLI) apply to everyday vascular surgery practice? Paper presented at Society for Vascular Surgery Vascular Annual Meeting, Boston, MA
    • Goodney PP, Schanzer A, DeMartino R, et al: Do objective performance goals (OPGs) for critical limb ischemia (CLI) apply to everyday vascular surgery practice? Paper presented at Society for Vascular Surgery Vascular Annual Meeting, Boston, MA, 2010.
    • (2010)
    • Goodney, P.P.1    Schanzer, A.2    DeMartino, R.3
  • 20
    • 33645810153 scopus 로고    scopus 로고
    • ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, a
    • Hirsch A.T., Haskal Z.J., Hertzer N.R., et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation 2006, 113:e463-e654.
    • (2006) Circulation , vol.113
    • Hirsch, A.T.1    Haskal, Z.J.2    Hertzer, N.R.3
  • 21
    • 24944529933 scopus 로고    scopus 로고
    • Risk factors, medical therapies and perioperative events in limb salvage surgery: observations from the PREVENT III multicenter trial
    • discussion 464-455
    • Conte M.S., Bandyk D.F., Clowes A.W., Moneta G.L., Namini H., Seely L. Risk factors, medical therapies and perioperative events in limb salvage surgery: observations from the PREVENT III multicenter trial. J Vasc Surg 2005, 42:456-464. discussion 464-455.
    • (2005) J Vasc Surg , vol.42 , pp. 456-464
    • Conte, M.S.1    Bandyk, D.F.2    Clowes, A.W.3    Moneta, G.L.4    Namini, H.5    Seely, L.6


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