Welcome to the BASIL-3 Trial Webpage

BASIL-3 is OPEN TO RECRUITMENT

16 Sep 2019

58 PATIENTS TO COMPLETE RECRUITMENT

Please note the telephone randomisation service will be closed from Friday 1300 hrs 20 Dec 2019 and will re-open Thursday 02 Jan 2020 at 0900 hrs due the Christmas break and University closed days. You can still randomise using the online randomisation database which is available 24/7. Please contact the trials office if you do not have access to this.

* 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.

The 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
Bedford Hospital	Mr Arindam Chaudhuri	29-oct-19

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.