Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010

Completed

• Conditions: Renal Angioplasty on Atherosclerotic Stenosis

• Registration Number: NCT03686358
• Lead Sponsor: Rennes University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-05-29
• Primary Completion: 2017-07-12
• Study Completion: 2017-07-12
• Status Verified: 2018-09
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-25
• Last Update Submitted: 2018-09-25
• Study First Posted: 2018-09-26
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite endpoint at 3 years	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.

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, Bretagne, France