NCT05834803

Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.

Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients - a Danish Nationwide Randomized Sham-Controlled Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to document a beneficial effect of percutaneous transluminal renal angioplasty (PTRA) of atherosclerotic renal artery stenosis in high-risk patients selected according to the criteria used in the DAN-PTRA study. The main questions the trial aims to answer are if renal artery stenting compared with optimal medical treatment alone has beneficial effects on: * Blood pressure * Kidney function * Hospitalizations for heart failure

Detailed description

Even with optimal medical care, patients with renovascular disease have a very high risk of cardiovascular events and an expected poor outcome. One treatment option of atherosclerotic renal artery stenosis is percutaneous transluminal renal angioplasty with stent placement. Renal artery stenting is, however, still a subject of debate as randomized trials have failed to show a benefit of this compared with optimal medical treatment alone. Following the results of the large CORAL trial in 2014, we established the national prospective DAN-PTRA study using strict and well-defined criteria to select patients for renal artery stenting. In this study, we observed a reduction in blood pressure, an improved kidney function, and a decrease in new hospital admissions due to heart failure after renal artery stenting. The DAN-PTRAII study is a nationwide high-quality randomized, sham-controlled clinical trial in patients with severe renovascular disease due to atherosclerotic renal artery stenosis. Only patients who fulfill the inclusion criteria on optimal medical treatment can enter the study and only the operator and his team will know whether the patients receive renal artery stenting or sham treatment. Participants will be followed closely for 6 months after the treatment to evaluate the effects of renal artery stenting compared with optimal medical treatment alone on blood pressure, kidney function and hospitalizations due to heart failure.

Conditions

• Renovascular Hypertension
• Renovascular Hypertension With Renal Failure
• Heart Failure
• Renal Artery Stenosis Atherosclerotic
• Percutaneous Transluminal Angioplasty

Interventions

Type	Name	Description
DRUG	Optimal medical therapy (OMT)	Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.
DIAGNOSTIC_TEST	Catheter-based angiography	Catheter-based angiography performed in accordance with the study protocol.
DIAGNOSTIC_TEST	Measurement of translesional pressure gradients	Measurement of translesional pressure gradients performed in accordance with the study protocol.
PROCEDURE	Renal artery stenting	Renal artery stenting performed in accordance with the study protocol.
PROCEDURE	Sham (No Treatment)	Sham procedure performed in accordance with the study protocol.

Timeline

• Start date: 2023-06-26
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-04-28
• Last updated: 2026-04-07

Locations

3 sites across 1 country: Denmark