Impact of Supra-renal Fixation of EVAR on Hemodynamics of Renal Arteries (IFIXEAR)

To Assess Hemodynamic Disturbances to the Ostia of the Renal Arteries Generated by the Implantation of EVAR With a Suprarenal Fixation

The investigators conducted a bicentric prospective study to quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation EVAR with suprarenal fixation immediately postoperatively.

Study Overview

• Status: Unknown
• Conditions: Aortic Aneurysm, Abdominal; Renal Artery Stenosis; Endovascular Procedures
• Intervention / Treatment: Device: endovascular aneurysm repair (EVAR)

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Costa, doctor; Phone Number: 0381668228; Email: pcosta@chu-besancon.fr
• Study Contact Backup: Name: Lucie Salomon du Mont, doctor; Email: lsalomondumont@chu-besancon.fr

Study Locations

• France
  • Besançon, France
    • Recruiting
    • Centre Hosptalier Universitaire
    • Contact: Patricia Costa, doctor
  • Dijon, France
    • Not yet recruiting
    • Centre Hospitalier Universitaire
    • Contact: Eric STEINMETZ, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• elective EVAR with supra renal fixation
• women who have been postmenopausal for at least 24 months or are surgically sterilized, or for women of childbearing potential, use of an effective method of contraception
• consent to participate
• Affiliation to a French social security

Exclusion Criteria:

• stenosis of at least one renal artery
• dialysis
• rupture of abdominal aortic aneurysm
• renal stenting during the procedure
• fenestrated EVAR
• legal incapacity or limited legal capacity
• subject being in the exclusion period of another study
• pregnant woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: endovascular aneurysm repair (EVAR) arm; every patients are in the same arm and have EVAR with supra-renal fixation	Device: endovascular aneurysm repair (EVAR); Patient will be enrolled when the decision of an endovascular procedure with supra renal fixation is required. Before the intervention, Duplex scan will be necessary to evaluate renal arteries ostia. This exam will be realised in the month after the intervention and one year later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic maximum speed at the ostia of the renal arteries	Quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of a suprarenal fixation aortic stent immediately postoperatively.	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic maximum speed at the ostia of the renal arteries	Quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of a suprarenal fixation aortic stent immediately postoperatively.	one year
proportion of patients with renal artery stenosis		one year
proportion of disappearance of the "notch" (pre-systolic notch)		one year
proportion of increase in systolic rise time		one year
proportion of decrease of the resistance index		one year
proportion of post-stenotic turbulence		one year
glomerular filtration rate	estimation of the glomerular filtration rate calculated by CKD-EPI between the preoperative and at one year	one year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Publications and helpful links

General Publications

• Salomon du Mont L, Parmentier AL, Puyraveau M, Mauny F, Guillon B, Rinckenbach S, Costa P. To assess hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of EVAR with a suprarenal fixation. Medicine (Baltimore). 2020 May;99(18):e19917. doi: 10.1097/MD.0000000000019917.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (ACTUAL): July 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Aortic Diseases; Renal Artery Obstruction; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 2017-A03047-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No