Skip to main content
. 2017 Apr 3;2017(4):CD002000. doi: 10.1002/14651858.CD002000.pub3
Study Reason for exclusion
ABC 2010 The ABC trial is a RCT comparing bypass surgery with angioplasty for the treatment of individuals suffering from IC caused by complex atherosclerotic lesions of the superficial femoral artery. As of 31/01/2012, this study was stopped because of participant recruitment issues. The principal investigator responded to our request of study results confirming that no results have ever been published or presented. The study protocol that was published in the European Journal of Vascular and Endovascular Surgery was withdrawn at the request of the study author(s) and/or editor.
CLEVER study This is a RCT evaluating outcomes of four treatment strategies for individuals with aorto‐iliac arterial disease manifesting with IC: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. It was excluded because there was no bypass surgery group in the treatment arms.
de Donato 2002 This is a RCT comparing minimally invasive direct aortic surgery with conventional transperitoneal laparotomy for aorto‐bifemoral bypass. It has, therefore, been excluded from this review because bypass was included in both arms of the trial and, therefore, there was no true control group.
Devine 2004 This is a RCT comparing heparin‐bonded Dacron prostheses or PTFE graft for use in femoro‐distal bypass. It has, therefore, been excluded from this review because bypass was included in both arms of the trial and, therefore, there was no true control group.
Djoric 2011 This is a RCT that compared distal venous arterialisation with conservative management using antiplatelet agents in individuals with CLI. This trial was excluded because there was no treatment group of individuals undergoing bypass surgery.
Gavrilenko 2008 This study evaluated results of the combination of vascular reconstructive surgery with gene‐engineering technologies in individuals with chronic lower limb ischaemia and was, therefore, excluded.
Gelin 2001 This is a RCT of individuals with IC. The objective of the study was to compare the effect of surgery, exercise, and observation on maximum exercise power. Participant were randomised to control, supervised exercise, or intervention group. Participants in the intervention group underwent an endovascular or open surgical procedure, but it is not specified which open surgical procedure(s) were used in the intervention group.
Hamsho 1999 This is a RCT of femoro‐distal bypass using PTFE grafts with and without the addition of adjuvant arterio‐venous fistula. It has, therefore, been excluded from this review because bypass was included in both arms of the trial and, therefore, there was no true control group.
IRONIC Trial This RCT compares invasive treatment (including endovascular and/or open revascularization) with best medical treatment in individuals with significant aorto‐iliac and/or femoro‐popliteal disease suffering from IC. This trial was excluded from our review and analysis because participants were randomised to any invasive treatment (surgical or endovascular) rather than bypass surgery.
Jensen 2007 This multicentre RCT had all 427 participants receiving bypass in both arms of the trial and was primarily a study comparing graft material.
Linhart 1991 This study was not clearly described, but appears to be a follow‐up study of two different methods of treatment. There is no mention of randomisation and the two different treatment options (surgery and medical therapy) were not compared in the analysis. Further information was sought from the study authors, but no reply was received.
Matyas 2008 This RCT was excluded because it compared variants of a surgical technique (bioresorbable paclitaxel‐eluting wrap implanted with a synthetic vascular graft versus the graft implanted alone) for femoro‐popliteal bypass.
McCollum 2003 Both arms of the trial underwent bypass, so there was no true control group. Furthermore, the study sought to compare types of graft material.
Mohammadi 2007 This 3‐year trial on 103 above‐knee femoro‐popliteal bypass graft operations in 85 individuals compared types of grafts. Additionally, all participants received bypass surgery, so there was no true control group.
Nordanstig 2011 This is a RCT comparing invasive (endovascular or surgical) and non‐invasive treatment for IC. This trial was excluded because enrolled participants were randomised to any invasive treatment (including surgical or endovascular) rather than bypass surgery.
Panneton 2004 This is a RCT comparing a pre‐cuffed PTFE graft with a vein‐cuffed PTFE graft for infrageniculate arterial bypass. It has, therefore, been excluded from this review because bypass was included in both arms of the trial and, therefore, there was no true control group.
PROOF 2007 This is a RCT comparing bypass surgery with plaque excision (Silverhawk Plaque Excision) for treatment of CLI. This trial has been terminated and no published results were found. The principal investigator was contacted to see whether any published or unpublished results could be obtained, but no response was received.
Stanisic 2009 This study evaluated laparoscopic techniques in individuals with CLI secondary to aorto‐iliac occlusive disease. It was excluded as it compares variants of a surgical technique.
Taft 2004 This is a RCT of individuals with IC who were randomised to control, supervised exercise, or intervention group. The objective of the study was to identify predictors of treatment outcome. Participants in the intervention group underwent an endovascular or open surgical procedure, but it was not specified which open surgical procedure(s) were used in the intervention group.
TECCO Trial This RCT compared endovascular with surgical reconstruction of common femoral artery disease. It was excluded from the present review because a minority only (18%) of the participant in the surgical treatment arm underwent bypass surgery for chronic lower limb ischaemia.
Tiek 2009 This is a nonrandomised study assessing the role of thrombolysis in acute infra‐inguinal bypass occlusion and was, therefore, excluded from the present review and analysis.
Tiek 2012 This is a RCT comparing a laparoscopic with an open surgical approach for the treatment of aorto‐iliac occlusive disease. It was excluded because it compared variants of a bypass surgical technique.
Vukobratov 2006 This study on 118 participants compared two methods of bypass. As all participants received bypass, there was no true control group.

CLI: critical limb ischaemia
 IC: intermittent claudication
 PTFE: polytetrafluoroethylene
 RCT: randomised controlled trial