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Multi-centre randomised controlled trial of the cost-effectiveness of infra-inguinal percutaneous transluminal angioplasty (PTA) versus reconstructive surgery for severe limb ischaemia
ISRCTN ISRCTN45398889
DOI 10.1186/ISRCTN45398889
ClinicalTrials.gov identifier
EudraCT number
Public title Multi-centre randomised controlled trial of the cost-effectiveness of infra-inguinal percutaneous transluminal angioplasty (PTA) versus reconstructive surgery for severe limb ischaemia
Scientific title
Acronym BASIL
Serial number at source HTA 96/05/01
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)
Lay summary
Ethics approval Not provided at time of registration.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cardiovascular diseases: Peripheral arterial disease
Participants - inclusion criteria Not provided at time of registration.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/03/1999
Anticipated end date 31/12/2007
Status of trial Completed
Patient information material
Target number of participants 452
Interventions 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
Primary outcome measure(s) 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 measure(s) Not provided at time of registration.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 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
Contact name Prof  Andrew  Bradbury
  Address University Department of Vascular Surgery
Solihull Hospital
Flat 5, Netherwood House
Lode Lane
Solihull
  City/town Birmingham
  Zip/Postcode B91 2JL
  Country United Kingdom
  Tel +44 (0)121 424 5086
  Fax +44 (0)121 424 5086
  Email Andrew.Bradbury@heartofengland.nhs.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Tel +44 (0)1132 545 843
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 25/04/2003
Last edited 21/06/2010
Date ISRCTN assigned 25/04/2003
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