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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686358
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Renal Angioplasty on Atherosclerotic Stenosis 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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010
Actual Study Start Date : May 29, 2017
Actual Primary Completion Date : July 12, 2017
Actual Study Completion Date : July 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty


Intervention Details:
  • Procedure: Renal artery angioplasty

    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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686358


Locations
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France
CHU Rennes
Rennes, Bretagne, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Thierry FROUGET CHU Rennes
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03686358    
Other Study ID Numbers: 35RC17_3069
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical