01/Sep/2021:

BASIL-3 has completed recruitment with 481 recruits!  

 24 Mar 2020:

COVID-19 STATEMENT 

***PLEASE ONLY CONTACT THE BASIL-3 OFFICE VIA E-MAIL***

BASIL-3@trials.bham.ac.uk

Important Message: COVID-19
We are working as normal during the COVID-19 pandemic. Responses may however take longer than normal as staff may be working altered hours but we are cross covering trials as required and urgent matters will be dealt with promptly. Please do contact our usual office/landline number or instead email the trial contact and copy in the trial mailbox (above). If a query requires a prompt response please mark as ‘urgent’ in the email subject header.

PLEASE CONTINUE FOLLOW-UPS REMOTELY via telephone and hospital systems.

SAEs

EMAIL ALL SAEs to the BASIL-3 email basil-3@trials.bham.ac.uk.  DO NOT FAX.  We will not be able to check the fax machine due to the lock down procedure. 

DATA

PLEASE SEND ALL DATA to the BASIL-3 email.  DO NOT FAX or SEND VIA POST.

RANDOMISATIONS

Randomisations can still take place via the basil-3 website.  However the randomisation hotline will not be in use. 

URGENT QUERIES

The BASIL-3 inbox is monitored as per usual working hours.  However in the event of urgent trial related queries or SAEs please contact 07708005652.

16 Sep 2019:

BASIL-3 is OPEN TO RECRUITMENT 

*** 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.  However due to the urgent safety measure in 2018 and the Sars-CoV-2 pandemic from 2020 onwards we have extended the recruitment period beyond the original three years. 

As of 01 September 2021, a total of 35 clinical centres are open to recruit to the Basil-3 trial; 29 in England, 3 in Scotland, and 2 in Wales.  All of the 35 clinical centres have cumulatively recruited 481 participants.  BASIL-3 has now completed recruitment and will continue to follow up BASIL-3 participants until August 2023.    

You can also see our clinical centres on the map.

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

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