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 |
| Protocol serial number | HTA 96/05/01 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. A reduction on all-cause mortality and requirement for major limb amputation (primary clinical end-points) |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
University Department of Vascular Surgery
Birmingham
B91 2JL
United Kingdom
B91 2JL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results on clinical and cost-effectiveness | 01/03/2010 | 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 | |
| Other publications | interim analysis | 03/12/2005 | Yes | No | |
| Other publications | trial discussion | 01/05/2010 | Yes | No | |
| Other publications | trial in perspective | 01/05/2010 | Yes | No |
