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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03594786
Acronym
IFIXEAR
Enrollment
70
Registered
2018-07-20
Start date
2018-06-01
Completion date
2021-06-01
Last updated
2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Abdominal, Endovascular Procedures, Renal Artery Stenosis

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.

Interventions

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.

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
systolic maximum speed at the ostia of the renal arteriesone monthQuantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of a suprarenal fixation aortic stent immediately postoperatively.

Secondary

MeasureTime frameDescription
proportion of patients with renal artery stenosisone year
proportion of disappearance of the notch (pre-systolic notch)one year
proportion of increase in systolic rise timeone year
systolic maximum speed at the ostia of the renal arteriesone yearQuantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of a suprarenal fixation aortic stent immediately postoperatively.
proportion of post-stenotic turbulenceone year
glomerular filtration rateone yearestimation of the glomerular filtration rate calculated by CKD-EPI between the preoperative and at one year
proportion of decrease of the resistance indexone year

Countries

France

Contacts

Primary ContactPatricia Costa, doctor
pcosta@chu-besancon.fr0381668228
Backup ContactLucie Salomon du Mont, doctor
lsalomondumont@chu-besancon.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026