Impact of Supra-renal Fixation of EVAR on Hemodynamics of Renal Arteries

Not Applicable

• Conditions: Renal Artery Stenosis; Aortic Aneurysm, Abdominal; Endovascular Procedures
• Interventions: Device: endovascular aneurysm repair (EVAR)

• Registration Number: NCT03594786
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-24
• Study Start: 2018-06-01
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Primary Completion: 2020-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endovascular aneurysm repair (EVAR) arm	endovascular aneurysm repair (EVAR)	every patients are in the same arm and have EVAR with supra-renal fixation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Centre Hosptalier Universitaire; 🇫🇷 Besançon, France

Centre Hospitalier Universitaire; 🇫🇷 Dijon, France