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Clinical Trials/NCT03594786
NCT03594786
Unknown
Not Applicable

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

Centre Hospitalier Universitaire de Besancon2 sites in 1 country70 target enrollmentJune 1, 2018
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ConditionsAortic Aneurysm, AbdominalEndovascular ProceduresRenal Artery Stenosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Aneurysm, Abdominal
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
70
Locations
2
Primary Endpoint
systolic maximum speed at the ostia of the renal arteries
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
June 1, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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
  • •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

Outcomes

Primary Outcomes

systolic maximum speed at the ostia of the renal arteries

Time Frame: 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 Outcomes

  • proportion of decrease of the resistance index(one year)
  • proportion of disappearance of the "notch" (pre-systolic notch)(one year)
  • systolic maximum speed at the ostia of the renal arteries(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)

Study Sites (2)

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