An observational study in Renal Artery Obstruction, Hypertension, Renovascular and Cardiovascular Diseases, sponsored by University of Aarhus. Recruiting at 5 sites in Denmark. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by University of Aarhus · Observational
A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA) in high-risk patients with renal artery stenosis selected on the basis of common national criteria, and with a common follow-up protocol for all three Danish centres offering PTRA
High-risk patients with renal artery stenosis
Eligibility criteria
Inclusion Criteria:
All of the following:
Exclusion Criteria:
Angioplasty plus stenting (angioplasty in patients with fibromuscular dysplasia) Adjuvant therapy in atherosclerotic renal artery stenosis - at the discretion of the treating physician * Antiplatelet therapy (usually standard) * Cholesterol-lowering drugs (usually standard) * Antihypertensive treatment with angiotensin-converting-enzyme inhibitor or angiotensin-receptor blocker (normally not contraindicated) * Smoking cessation, diet and physical activity (usually standard)
Changes in 24-hour ambulatory systolic and diastolic blood pressures from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline
Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline and with significant artery stenosis either 1. Unilaterally (one or two kidneys) 2. Bilaterally with treatment of both kidneys All 24-hour ambulatory blood pressure measurements are performed after nurse-administered medication. Likewise, it will below be inferred that renal artery stenosis is defined as in the primary endpoint.
Time frame: Measured 24 months post-PTRA
Changes in 24-hour ambulatory systolic and diastolic blood pressures from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline
Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline and with significant artery stenosis
Time frame: Measured 24 months post-PTRA
Changes in 24-hour ambulatory systolic and diastolic blood pressures (statistically adjusted for treatment changes) from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline
Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) (statistically adjusted for treatment changes) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline and with significant artery stenosis
Time frame: Measured 24 months post-PTRA
Changes in 24-hour ambulatory systolic and diastolic blood pressures (statistically adjusted for treatment changes) from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline
Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) (statistically adjusted for treatment changes) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline and with significant artery stenosis
Time frame: Measured 24 months post-PTRA
Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes)
Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes) from baseline to 3, 12, 36, 48 and 60 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg and in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg
Time frame: Measured at 3, 12, 36, 48 and 60 months
Change in antihypertensive treatment (defined daily doses)
Time frame: Measured at 3, 12, 24, 36, 48 and 60 months
Change in kidney function
Change in estimated glomerular filtration rate (eGFR) and change in percentage side distribution measured by renography at baseline and 24 months after PTRA
Time frame: Measured at 3, 12, 24, 36, 48 and 60 months
Clinical composite end point
Clinical composite end point 1. death from cardiovascular causes 2. death from renal causes 3. stroke 4. myocardial infarction 5. hospitalization for congestive heart failure 6. progressive renal insufficiency (a reduction from baseline of 30% or more in eGFR) 7. permanent renal-replacement therapy Only the first event per participant is included in the composite
Time frame: Measured at 3, 12, 24, 36, 48 and 60 months
Safety composite end point (< 30 days after PTRA)
Safety composite end point (\< 30 days after PTRA) 1. all cause mortality 2. rupture, dissection, perforation or occlusion of renal artery 3. critical bleeding (need of blood transfusion) 4. embolization 5. significant loss of kidney function (reduction from baseline of 30% or more in eGFR) 6. ipsilateral nephrectomy 7. pseudoaneurysm formation 8. stent thrombosis Only the first event per participant is included in the composite
Time frame: Measured at 3, 12, 24, 36, 48 and 60 months
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University of Aarhus