Condition category
Circulatory System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
21/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andrew Bradbury

ORCID ID

Contact details

University Department of Vascular Surgery
Solihull Hospital
Flat 5
Netherwood House
Lode Lane
Solihull
Birmingham
B91 2JL
United Kingdom
+44 (0)121 424 5086
Andrew.Bradbury@heartofengland.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/05/01

Study information

Scientific title

Acronym

BASIL

Study hypothesis

To determine by means of a multi-centre, randomised controlled trial whether, in patients with severe lower limb ischaemia, adopting a 'PTA first' strategy rather then the traditional 'surgery first' strategy is associated with a better outcome in terms of:
a. A reduction on all-cause mortality and requirement for major limb amputation (primary clinical end-points)
b. Abolition of symptoms, procedure complications, secondary and cross-over interventions, minor amputation, quality of life measures and cost-effective utilisation of NHS resources (secondary end-points)

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular diseases: Peripheral arterial disease

Intervention

Please note that, as of 15 January 2008, the end date of this trial has been updated from 31 January 2004 to 31 December 2007.

Interventions:
1. Percutaneous transluminal angioplasty (PTA)
2. Standard reconstructive surgery

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. A reduction on all-cause mortality and requirement for major limb amputation (primary clinical end-points)
2. Abolition of symptoms, procedure complications, secondary and cross-over interventions, minor amputation, quality of life measures and cost-effective utilisation of NHS resources (secondary end-points)

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/03/1999

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

452

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/1999

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Department of Vascular Surgery
Birmingham
B91 2JL
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 interim analysis in http://www.ncbi.nlm.nih.gov/pubmed/16325694
2. 2010 results on clinical and cost-effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/20307380
3. 2010 trial in perspective in http://www.ncbi.nlm.nih.gov/pubmed/20435257
4. 2010 results of intention-to-treat analysis of amputation-free and overall survival in patients in http://www.ncbi.nlm.nih.gov/pubmed/20435258
5. 2010 results of analysis of amputation free and overall survival by treatment received in http://www.ncbi.nlm.nih.gov/pubmed/20435259
6. 2010 results on severity and extent of disease in http://www.ncbi.nlm.nih.gov/pubmed/20435260
7. 2010 results of health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis in http://www.ncbi.nlm.nih.gov/pubmed/20435261
8. 2010 results on a survival prediction model to facilitate clinical decision making in http://www.ncbi.nlm.nih.gov/pubmed/20435262
9. 2010 trial discussion in http://www.ncbi.nlm.nih.gov/pubmed/20435263

Publication citations

  1. Interim analysis

    Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H, , Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial., Lancet, 2005, 366, 9501, 1925-1934, doi: 10.1016/S0140-6736(05)67704-5.

  2. Trial in perspective

    Bradbury AW, , Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial in perspective., J. Vasc. Surg., 2010, 51, 5 Suppl, 1S-4S, doi: 10.1016/j.jvs.2010.02.002.

  3. Results of analysis of amputation free and overall survival by treatment received

    Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Ruckley CV, Raab GM, , 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, 5 Suppl, 18S-31S, doi: 10.1016/j.jvs.2010.01.074.

  4. Results on severity and extent of disease

    Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Ruckley CV, Raab GM, , Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: A description of the severity and extent of disease using the Bollinger angiogram scoring method and the TransAtlantic Inter-Society Consensus II classification., J. Vasc. Surg., 2010, 51, 5 Suppl, 32S-42S, doi: 10.1016/j.jvs.2010.01.075.

  5. Results on a survival prediction model to facilitate clinical decision making

    Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Ruckley CV, Raab GM, , Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: A survival prediction model to facilitate clinical decision making., J. Vasc. Surg., 2010, 51, 5 Suppl, 52S-68S, doi: 10.1016/j.jvs.2010.01.077.

  6. Trial discussion

    Conte MS, 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, 5 Suppl, 69S-75S, doi: 10.1016/j.jvs.2010.02.001.

  7. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Raab G, Ruckley CV, Multicentre randomised controlled trial of the clinical and cost-effectiveness of a bypass-surgery-first versus a balloon-angioplasty-first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial., Health Technol Assess, 2010, 14, 14, 1-210, iii-iv, doi: 10.3310/hta14140.

  8. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Ruckley CV, Raab GM, , 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, 5 Suppl, 5S-17S, doi: 10.1016/j.jvs.2010.01.073.

  9. Forbes JF, Adam DJ, Bell J, Fowkes FG, Gillespie I, Raab GM, Ruckley CV, Bradbury AW, , Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis., J. Vasc. Surg., 2010, 51, 5 Suppl, 43S-51S, doi: 10.1016/j.jvs.2010.01.076.

Additional files

Editorial Notes