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ISRCTN
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ISRCTN45398889
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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BASIL
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Serial number at source
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HTA 96/05/01
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Study hypothesis
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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)
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular diseases: Peripheral arterial disease
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Participants - inclusion criteria
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Not provided at time of registration.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/03/1999
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Anticipated end date
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31/12/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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452
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Interventions
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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
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Primary outcome measure(s)
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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)
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16325694
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Contact name
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Prof
Andrew
Bradbury
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Address
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University Department of Vascular Surgery
Solihull Hospital
Flat 5, Netherwood House
Lode Lane
Solihull
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City/town
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Birmingham
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Zip/Postcode
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B91 2JL
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Country
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United Kingdom
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Tel
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+44 (0)121 424 5086
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Fax
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+44 (0)121 424 5086
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Email
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Andrew.Bradbury@heartofengland.nhs.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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15/01/2008
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Date ISRCTN assigned
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25/04/2003
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