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

Aortic Aneurysm, Abdominal Clinical Trial

— IFIXEAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594786
• Other study ID #: 2017-A03047-46
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Patricia Costa, doctor
• Phone: 0381668228
• Email: pcosta[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endovascular Procedures
• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hosptalier Universitaire	Besançon
France	Centre Hospitalier Universitaire	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	proportion of patients with renal artery stenosis		one year
Secondary	proportion of disappearance of the "notch" (pre-systolic notch)		one year
Secondary	proportion of increase in systolic rise time		one year
Secondary	proportion of decrease of the resistance index		one year
Secondary	proportion of post-stenotic turbulence		one year
Secondary	glomerular filtration rate	estimation of the glomerular filtration rate calculated by CKD-EPI between the preoperative and at one year	one year