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 | https://doi.org/10.1186/ISRCTN45398889 |
| Secondary identifying numbers | HTA 96/05/01 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 21/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andrew Bradbury
Scientific
Scientific
University Department of Vascular Surgery
Solihull Hospital
Flat 5, Netherwood House
Lode Lane
Solihull
Birmingham
B91 2JL
United Kingdom
| Phone | +44 (0)121 424 5086 |
|---|---|
| Andrew.Bradbury@heartofengland.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | BASIL |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/1999 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 452 |
| Key inclusion criteria | Not provided at time of registration. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/1999 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Department of Vascular Surgery
Birmingham
B91 2JL
United Kingdom
B91 2JL
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | interim analysis | 03/12/2005 | Yes | No | |
| Results article | results on clinical and cost-effectiveness | 01/03/2010 | Yes | No | |
| Other publications | trial discussion | 01/05/2010 | Yes | No | |
| Other publications | trial in perspective | 01/05/2010 | Yes | No | |
| Results article | results of analysis of amputation free and overall survival by treatment received | 01/05/2010 | Yes | No | |
| Results article | results of health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis | 01/05/2010 | Yes | No | |
| Results article | results of intention-to-treat analysis of amputation-free and overall survival in patients | 01/05/2010 | Yes | No | |
| Results article | results on a survival prediction model to facilitate clinical decision making | 01/05/2010 | Yes | No | |
| Results article | results on severity and extent of disease | 01/05/2010 | Yes | No |
