RecruitingNot ApplicableNCT05834803

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.


Sponsor

University of Aarhus

Enrollment

80 participants

Start Date

Jun 26, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a minimally invasive procedure to open up a narrowed kidney artery (called renal angioplasty with stenting) helps people with both severe kidney artery blockage AND difficult-to-control blood pressure, rapidly declining kidney function, or recurrent heart failure episodes. Standard medical management alone often falls short for these high-risk patients. **You may be eligible if...** - You have been found to have a significant kidney artery narrowing (70% or more blockage) confirmed by angiography - You also have at least one of: blood pressure that cannot be controlled on 3+ medications, rapidly worsening kidney function, or repeated hospitalizations for sudden heart failure ("flash" pulmonary edema) **You may NOT be eligible if...** - You have had prior kidney artery stenting - You have had a kidney transplant - Your kidney is very small (less than 7 cm) - Your kidney artery narrowing is due to a non-hardening-of-the-arteries cause (e.g., fibromuscular dysplasia) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOptimal 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_TESTCatheter-based angiography

Catheter-based angiography performed in accordance with the study protocol.

DIAGNOSTIC_TESTMeasurement of translesional pressure gradients

Measurement of translesional pressure gradients performed in accordance with the study protocol.

PROCEDURERenal artery stenting

Renal artery stenting performed in accordance with the study protocol.

PROCEDURESham (No Treatment)

Sham procedure performed in accordance with the study protocol.


Locations(3)

Aarhus University Hospital

Aarhus N, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense C, Denmark

View Full Details on ClinicalTrials.gov

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NCT05834803


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