As of June 2003, 276 patients had been recruited into the Angioplasty and STent for Renal Artery Lesions (ASTRAL) trial; 49 centres are now recruiting into ASTRAL, a further 20 with Local Research Ethics Committees (LREC) approval are yet to randomise and two centres are awaiting LREC approval.
This makes ASTRAL already the largest-ever randomised trial in atherosclerotic renovascular disease (ARVD) by some margin. New centres continue to join the trial, but organisers require more hospitals to enter patients if ASTRAL is going to provide truly reliable results with which to guide the treatment of arrhythmogenic right ventricular dysplasia (ARVD).
A few months ago the trial’s protocol was amended to allow patients to be randomised into ASTRAL trial on the basis of Magnetic Resonance Angiography (MRA) and Computed Tomography (CT) angiography. The trial administrators acknowledge that the quality of MR scanners, software and resulting image quality will vary between centres and it may be that local clinicians will have their own validation data for angiographic concordance. Nevertheless, they recommend that those centres who randomise on the basis of MRA should use slight caution when moderate RAS lesions are detected.