Nephrology Urological and Genital Diseases Renal failure
Conditions
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 w
Sponsors
University of Birmingham (UK)
Eligibility
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
England, United Kingdom
Outcome results
None listed