Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010 (PARAS)
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|ClinicalTrials.gov Identifier: NCT03686358|
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
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|
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|
|Actual Enrollment :||80 participants|
|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|
- 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
- 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.
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
|Rennes, Bretagne, France, 35000|
|Principal Investigator:||Thierry FROUGET||CHU Rennes|