Angioplasty and stent for renal artery lesions
| ISRCTN | ISRCTN59586944 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59586944 |
| Secondary identifying numbers | G0000995 |
- Submission date
- 02/05/2001
- Registration date
- 02/05/2001
- Last edited
- 15/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K Wheatley
Scientific
Scientific
University of Birmingham Clinical Trials Unit
Park Grange
1 Somerset Road
Edgbaston
Birmingham
B15 2RR
United Kingdom
| a@a |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Angioplasty and stent for renal artery lesions |
| Study acronym | ASTRAL |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nephrology |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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). |
| Overall study start date | 01/09/2000 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 750 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham Clinical Trials Unit
Birmingham
B15 2RR
United Kingdom
B15 2RR
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.bham.ac.uk/ |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | interim results | 01/07/2007 | Yes | No | |
| Results article | results | 12/11/2009 | Yes | No | |
| Results article | Long Term Outcomes | 15/08/2024 | 15/08/2024 | Yes | No |
Editorial Notes
15/08/2024: Publication reference added.
