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

Study Overview
=================
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.

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

Conditions
-----------------
Aortic Aneurysm, Abdominal, Endovascular Procedures, Renal Artery Stenosis

Intervention / Treatment
-----------------
* Device: endovascular aneurysm repair (EVAR)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endovascular aneurysm repair (EVAR) arm<br>every patients are in the same arm and have EVAR with supra-renal fixation | Device: endovascular aneurysm repair (EVAR)<br>* 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.<br>|

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 |