*** 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.  

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)

 

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

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