Angioplasty and stent for renal artery lesions

ISRCTN	ISRCTN59586944
DOI	https://doi.org/10.1186/ISRCTN59586944
Protocol serial number	G0000995
Sponsor	University of Birmingham (UK)
Funder	Medical Research Council (MRC) (UK)

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

University of Birmingham Clinical Trials Unit
Park Grange
1 Somerset Road
Edgbaston
Birmingham
B15 2RR
United Kingdom

Email	a@a

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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.
Key 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).
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

University of Birmingham Clinical Trials Unit

Birmingham
B15 2RR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/11/2009		Yes	No
Results article	Long Term Outcomes	15/08/2024	15/08/2024	Yes	No
Interim results article	interim results	01/07/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/08/2024: Publication reference added.