Kidney artery stenting versus sham procedure in high-risk renal artery stenosis
Tests a kidney artery stent against a sham procedure in high-risk adults.
Plain-language title generated from the registry record
Registry title: Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Key facts
- Where
- Aarhus N, Copenhagen, and Odense C, DenmarkSee the 3 sites
Where in Denmark
- Aarhus University HospitalAarhus N, DenmarkTaking people
- RigshospitaletCopenhagen, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT05834803
- Record updated
- 4 November 2026
- Original description
The goal of this clinical trial is to investigate whether percutaneous transluminal renal angioplasty (PTRA) with stent placement of atherosclerotic renal artery stenosis is beneficial in high-risk patients selected according to the criteria used in the DAN-PTRAI study. The main questions the trial aims to answer are whether renal artery stenting in addition to optimal medical therapy, compared with a sham procedure and optimal medical therapy, has beneficial effects on:Read full original descriptionShow less
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients - a Danish Nationwide Randomized Sham-Controlled Study.
The goal of this clinical trial is to investigate whether percutaneous transluminal renal angioplasty (PTRA) with stent placement of atherosclerotic renal artery stenosis is beneficial in high-risk patients selected according to the criteria used in the DAN-PTRAI study. The main questions the trial aims to answer are whether renal artery stenting in addition to optimal medical therapy, compared with a sham procedure and optimal medical therapy, has beneficial effects on:
* Blood pressure (primary outcome: 24-hour ambulatory systolic blood pressure at 6 months) * Kidney function * Hospitalizations for heart failure
Inclusion: One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography; In addition, at least one of the following high-risk clinical syndromes:; Resistant hypertension with average 24-hour ambulatory systolic blood pressure ≥150 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses; Rapidly declining kidney function with a reduction in estimated GFR of >5 mL/min per 1.73m2 per year and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses; Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalization for sudden, "flash" pulmonary edema) with no obvious explanations such as nonadherence, left ventricular ejection fraction <40%, or valvular heart disease and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses; All 24-hour ambulatory blood pressure measurements are performed after nurse-administered medication.
Exclusion: Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization; Previous kidney transplant; Previous PTRA with stent placement; Presence of a renal artery stenosis not amenable for treatment with a stent; Intolerance to any antithrombotic treatment; Patients who are not eligible for randomization but treated with renal artery stenting outside the protocol are followed according to the DAN-PTRAII protocol in order to account for all PTRA treatments performed in Denmark in the study period; Patients treated with renal artery stenting without randomization in the study period include patients with:; Treatment-resistant heart failure episodes presumed caused by renovascular disease; Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease; Treatment-resistant heart failure episodes presumed caused by renovascular disease; Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease; At least one of the listed high-risk clinical syndromes AND one or more significant atherosclerotic renal artery stenoses defined as a stenosis of 50-69% by catheter-based angiography with:; a mean translesional gradient of ≥10 mmHg, or; a systolic translesional gradient of ≥20 mmHg, or; a renal fractional flow reserve (Pd/Pa) of ≤0.80; Unable to provide informed consent; Pregnancy or unknown pregnancy status in female of childbearing potential; Kidney size <7 cm (pole to pole length) supplied by target vessel.