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Welcome to the BASIL-3 Trial Webpage

*** Following the MHRA statement released on the 4th June 2019, BASIL-3 will be re-opening to recruitment as per this statement ***

The Expert Advisory Group for the MHRA published a report advising trials such as BASIL-3 should consider resuming recruitment.  The was reflected in the MHRA MDA (MDA/2019/023) stating the use of paclitaxel devices should still be considered for the treatment of CLTI in accordance to NICE. 

The Global Vascular Guidelines released new guidelines on the management of CLTI (June 2019) which included the following statement:

the risks and benefits of treatment for CLTI, including drug-eluting devices, need to be examined with appropriately controlled prospective studies that are specific to the CLTI population, the execution of randomised controlled-trials involving PTX-eluting devices in CLTI, with appropriate safety monitoring and regulatory oversight are important to the vascular community. Page 104S, Conte et al, GVG on management of CLTI June 2019

The GVG is endorsed by the VSGBI, BSIR and BSET.

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. 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.

 

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

Trial Progress

Basil-3 officially 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. 

As of 13 Jun 2019, a total of 34 clinical centres are open to recruit to the Basil-3 trial; 29 in England, 3 in Scotland, and 2 in Wales.  All of the 34 clinical centres have cumulatively recruited 411 participants.  Once recruitment is resumed we hope to open two more centres in 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

Royal Berkshire

Dr Farhan Ahmad 

22-Jan-18

 

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 (end of DEC 2018)

 Last recruitment graph before pause

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