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Welcome to the BASIL-3 Trial Webpage

*** The BASIL-3 protocol paper has now been published in "Trials" and can be accessed from their website ***

Introduction 

Basil-3 is a multi-centre randomised controlled trial of clinical and cost-effectiveness of drug coated balloons, drug eluting stents, and plain balloon angioplasty with bail-out bare metal stent revascularisation strategies for severe limb ischaemia secondary to femoro-popliteal disease.

 

nihr_colourThe BASIL-3 Trial is funded by a NIHR Health Technology Assessment grant (project number 13/81/02).

Severe limb ischemia is the most serious and debilitating form of lower limb peripheral artery disease and is a seriously disabling, life and limb threatening, condition. The aim of BASIL-3 is to evaluate the clinical efficacy and cost-effectiveness of the interventions for people with severe limb ischaemia.

Trial Progress

Basil-3 officialy began its 3-year recruitment phase in February 2016, however due to receiving regulatory approval ahead of schedule, the lead centre (Heart of England NHS Foundation Trust) successfully entered the trial's first two participants during January of 2016. Since then, the trial has managed to meet or exceed each of its monthly targets, which are set by the National Institute for Health Research's HTA programme. This early success has firmly placed the cumulative recruitment total ahead of schedule.

As of 02 October 2017, a total of 33 clinical centres are open to recruit to the Basil-3 trial; 28 in England, 3 in Scotland, and 2 in Wales.  Thirty-two of the 33 clinical centres have cumulatively recruited 238 participants. We have 2 clinical centres which we anticipate will open to recruitment in the next 30 days. Tens of centres have formally expressed interest in opening Basil-3 and are at varying stages of start-up; we anticipate the majority of these opening within the next six months.

 

Basil-3 Trial Centres

 

Clinical centres currently open to recruit to Basil-3

 Centre name Local PI Opened

North Cumbria University Hospitals 

Mr Ron Eifell

12-Jan-16 

Royal Cornwall Hospitals

Mr Harvey Chant

 19-Jan-16

Heart of England NHS FT

Prof. Andrew Bradbury

 19-Jan-16

Sheffield Teaching Hospitals

Dr Stephen Goode

24-Feb-16 

Pennine Acute Hospitals

Dr Khalid Bashaeb

14-Mar-16

County Durham and Darlington

Mr Philip Davey

18-Mar-16

East Kent Hospitals

Dr Neelan Das

07-Apr-16

Colchester Hospital University

Dr Nagendra Thayur 

24-May-16 

Dorset County Hospital

Mr James Metcalfe 

28-May-16 

Imperial College Healthcare

Prof. Alun Davies 

21-Jun-16 

Aneurin Bevan Health Board

Mr Christopher Twine 

21-Jun-16 

United Lincolnshire Hospitals

Dr Geurino Centini 

11-Aug-16

Russell's Hall Hospital (Dudley)

Mr Simon Hobbs

23-Aug-16

Nottingham University Hospitals

Dr Said Habib

09-Sep-16

Basildon Hospital

Dr Jeremy Rabouhans

12-Sep-16

University Hospitals of North Midlands

Dr John Asquith

07-Oct-16

Freeman Hospital (Newcastle)

Prof. Gerard Stansby

19-Oct-16

Frimley Park Hospital

Mr Patrick Chong

08-Nov-16

Royal Infirmary of Edinburgh

Dr Graeme Weir

18-Nov-16

Leeds General Infirmary

Dr Jai Patel

18-Nov-16

Royal Wolverhampton Hospitals

Mr Simon Hobbs

13-Dec-16

Leicester Royal Infirmary

Mr Robert Davies

30-Jan17

University Hospital of Wales

Dr Richard White

31-Jan-17

Dumfries and Galloway Royal Infirmary

Mr Joseph Sathianathan

31-Jan-17

Royal Sussex County Hospital

Mr Mario Caruana

07-Feb-17

Hull Royal Infirmary

Prof. Ian Chetter

09-Feb-17

St. Thomas' Hospital

Mr Hany Zayed

28-Feb-17

Southmead Hospital (Bristol)

Dr Alexander Horsch

13-Apr-17

Royal Bournemouth

Mr Lasantha Wijesinghe

17-May-17

University Hospital of South Manchester

Mr Ray Ashleigh

19-May-17

Manchester Royal Infirmary

Mr Tawqeer Rashid

25-May-17

Forth Valley Royal Hospital

Dr Nik Arestis

02-Aug-17

St. George's Hospital

Dr Raj Das

16-Aug-17

 

You can also see our clinical centres on the map.

The Basil-3 trial team are still accepting expressions of interest from UK-based vascular centres. NHS Trusts in England and Health Boards in the devolved nations should contact the Basil-3 trial office with the name of their proposed Principal Investigator to begin the start-up process for their site. We would typically expect a site Principal Investigator to be a Consultant Interventional Radiologist or a Consultant Vascular Surgeon with prior clinical research experience. Please see the contact us page for details of how to get in touch.

Current Basil-3 Recruitment (as of end of August 2017)

 Cummlative Recruitment Aug 17

For a more in depth overview of recruitment to Basil-3, visit our recruitment page.