Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010 (PARAS)

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.

Study Overview

• Status: Completed
• Conditions: Renal Angioplasty on Atherosclerotic Stenosis
• Intervention / Treatment: Procedure: Renal artery angioplasty

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • Chu Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients having undergone renal arterial angioplasty on atherosclerotic stenosis between 01/01/2010 and 12/31/2013 at Rennes University Hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint at 3 years	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.	The inclusion day

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Thierry FROUGET, Chu Rennes

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2017
• Primary Completion (Actual): July 12, 2017
• Study Completion (Actual): July 12, 2017

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 35RC17_3069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No