Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010

Renal Angioplasty on Atherosclerotic Stenosis Clinical Trial

— PARAS  

Official title:

Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686358
• Other study ID #: 35RC17_3069
• Status: Completed
• Start date: May 29, 2017
• Est. completion date: July 12, 2017

Study information

• Verified date: September 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 12, 2017
• Est. primary completion date: July 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Renal Angioplasty on Atherosclerotic Stenosis

Intervention

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

Locations

Country	Name	City	State
France	CHU Rennes	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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