Angioplasty and stent for renal artery lesions

niversity of Birmingham (UK)0 sites750 target enrollmentMay 2, 2001

Overview

2007 Interim results article in http://www.ncbi.nlm.nih.gov/pubmed/17377602 interim results 2009 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19907042 results 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39145377/ Long Term Outcomes (added 15/08/2024)

Registry

who.int

Start Date

May 2, 2001

End Date

October 1, 2007

Last Updated

last year

Study Type

Interventional

Sponsor

niversity of Birmingham (UK)

•1\. Atherosclerotic renovascular disease (ARVD) confirmed angiographically
•2\. At least one ARVD lesion that is suitable for revascularisation
•3\. No definite indication for, or contraindication to, revascularisation, and revascularisation unlikely to become definitely indicated within 6 months of entry
•4\. Informed consent obtained from patient

•1\. Non\-atherosclerotic renal arterial lesion (i.e. fibromuscular dysplasia).
•2\. Previous revascularisation procedure for ARVD.
•3\. Clear contraindication to revascularisation.
•Eligibility will be based on the uncertainty principle. That is, if there is a clear indication for, or contraindication to, revascularisation, that patient is not eligible for entry into ASTRAL. If, on the other hand, the patient's medical team is uncertain whether or not to revascularise, then that patient is eligible for randomisation. This approach allows an appropriately heterogeneous population of patients to be entered (since different clinicians will have varying areas of uncertainty), thereby leading to results which are more generalisable to the 'real world' and permitting investigation of treatment effects in different types of patient.