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Angioplasty and stent for renal artery lesions
ISRCTN ISRCTN59586944
DOI 10.1186/ISRCTN59586944
ClinicalTrials.gov identifier
EudraCT number
Public title Angioplasty and stent for renal artery lesions
Scientific title
Acronym ASTRAL
Serial number at source G0000995
Study hypothesis The ASTRAL trial is designed to address the issue of whether renal arterial revascularisation with balloon angioplasty and/or endovascular stenting can safely prevent progressive renal failure among a wide range of patients with atherosclerotic renovascular disease.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Nephrology
Participants - inclusion criteria 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
Participants - exclusion criteria 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.
Anticipated start date 01/09/2000
Anticipated end date 01/10/2007
Status of trial Completed
Patient information material
Target number of participants 750
Interventions Patients in both arms will receive active intervention:
1. In the revascularisation arm, balloon angioplasty and/or endovascular stenting with medical management
2. In the medical therapy arm, drugs will be prescribed as considered appropriate
Primary outcome measure(s) The primary outcome measure is decline in renal function, as assessed by the slope of the reciprocal creatinine plot against time. Although single measures of serum creatine are a poor indicator of renal function in individual patients, serial measurements over up to 5 years will be made so patterns of change will be detectable. Furthermore, the assessment of differences in renal function between the two treatment arms with reciprocal creatine plots is statistically appropriate since the important factor is the average change in renal function with or without revascularisation.
Secondary outcome measure(s) Secondary end points are: blood pressure, urinary protein excretion; serious vascular events (such as myocardial infarction or stroke) and other event rates (including death and the need for dialysis); safety; and a single measure of angiographic patency at one year (in a subset of patients).
Sources of funding Medical Research Council (MRC) (UK)
Trial website http://www.astral.bham.ac.uk/
Publications 1. 2007 interim results in http://www.ncbi.nlm.nih.gov/pubmed/17377602
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19907042
Contact name Dr  K  Wheatley
  Address University of Birmingham Clinical Trials Unit
Park Grange
1 Somerset Road
Edgbaston
  City/town Birmingham
  Zip/Postcode B15 2RR
  Country United Kingdom
  Email
Sponsor University of Birmingham (UK)
  Address Edgbaston
  City/town Birmingham
  Zip/Postcode B15 2TT
  Country United Kingdom
  Email
  Sponsor website: http://www.bham.ac.uk/
Date applied 02/05/2001
Last edited 12/09/2011
Date ISRCTN assigned 02/05/2001
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