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

September 25, 2018 updated by: Rennes University Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bretagne
      • Rennes, Bretagne, France, 35000
        • CHU Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The inclusion day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Thierry FROUGET, CHU Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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