Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010

NCT ID: NCT03686358

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-29
• Study Completion Date: 2017-07-12

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.

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.

Conditions

Renal Angioplasty on Atherosclerotic Stenosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry FROUGET

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

CHU Rennes

Rennes, Brittany Region, France

Countries

France

Other Identifiers

35RC17_3069

Identifier Type: -

Identifier Source: org_study_id