Completed

NCT Number: NCT03686358

Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010

The interest of renal angioplasty in the nosological framework of atherosclerotic stenosis has been significantly challenged by STAR and ASTRAL clinical trials in 2009, confirmed by the CORAL study in 2014.

These studies did not show any benefit of the gesture on renal function, morbidity and cardiovascular mortality or the tension control. The aim of the study is to evaluate renal angioplasty on atherosclerotic stenosis.

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Key information

Conditions

Renal Angioplasty on Atherosclerotic Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Rennes

Rennes, Brittany Region, 35000, France

About this study

Previous studies did not concern the indication of renal angioplasty in some high-risk situations, such as malignant or resistant renal vascular hypertension, OAP (Acute pulmonary oedema) flash or acute renal failure of ischemic origin.

There is no work in the literature that has studied retrospectively the evolution of angioplasty practices renal artery disease on atherosclerotic stenosis since 2009, nor their remote results of the gesture.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

OAP flash: hospitalization for Acute congestive heart failure without any other identified etiology than renal artery stenosis
Resistant arterial hypertension under treatment including a diuretic
Acute renal failure or ischemic renal failure quickly progressive
Radiological criteria: renal ischemia visualized at arterial time of angio-CT or renal angio-MRI

Exclusion criteria

Renal transplant patients
Patients with another etiology of secondary hypertension, including fibro-muscular dysplasia of renal artery
Restenosis on stent, angioplasty of accessory renal artery
Patients subject to legal protection (safeguard of justice, guardianship) and persons deprived of liberty
Patients objecting to participate to the study

Treatment and study plan

Renal artery angioplasty

Procedure

Patients meeting the inclusion criteria were selected from the medical records of renal angioplasty performed at the Rennes University Hospital between 01/01/2010 and 12/31/2013. Each selected patient will receive a notice by mail of information. In the absence of opposition from them within a two weeks, the processing of their data will begin :

Evaluation of the results at 3 years of renal angioplasty on atherosclerotic stenosis performed at Rennes University Hospital
Evaluation of indications of renal angioplasty on stenosis atherosclerosis performed after 2009 at Rennes University Hospital
Identification of prognostic factors

Primary outcomes

Composite endpoint at 3 years

Time frame: The inclusion day
Composite endpoint at 3 years :
- Cardiovascular or renal mortality,
- Initiation of a renal replacement therapy or estimated glomerular filtration rate decrease of more than 50%, Cardiovascular morbidity: hospitalization for congestive heart failure, myocardial infarction, myocardium, stroke.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: PARAS

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Sep 26, 2018
Registry last updated: Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.