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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Renal Artery Stenosis; Aortic Aneurysm, Abdominal; Endovascular Procedures

Treatments: Device: endovascular aneurysm repair (EVAR)

Study type: Interventional

Funder types: Other

Identifiers

NCT03594786

2017-A03047-46

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

endovascular aneurysm repair (EVAR) arm

Experimental group

Description:

every patients are in the same arm and have EVAR with supra-renal fixation

Treatment:

Device: endovascular aneurysm repair (EVAR)