Angioplasty and stent for renal artery lesions

niversity of Birmingham (UK)0 个研究点目标入组 750 人开始时间: 2001年5月2日最近更新: 2024年8月26日

适应症

试验速览

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)

•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.

发起方

niversity of Birmingham (UK)