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

Primary Purpose

Aortic Aneurysm, Abdominal, Endovascular Procedures, Renal Artery Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
endovascular aneurysm repair (EVAR)
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Aneurysm, Abdominal

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hosptalier UniversitaireRecruiting
  • Centre Hospitalier Universitaire

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endovascular aneurysm repair (EVAR) arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2018
Last Updated
March 9, 2020
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03594786
Brief Title
Impact of Supra-renal Fixation of EVAR on Hemodynamics of Renal Arteries
Acronym
IFIXEAR
Official Title
To Assess Hemodynamic Disturbances to the Ostia of the Renal Arteries Generated by the Implantation of EVAR With a Suprarenal Fixation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal, Endovascular Procedures, Renal Artery Stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endovascular aneurysm repair (EVAR) arm
Arm Type
Experimental
Arm Description
every patients are in the same arm and have EVAR with supra-renal fixation
Intervention Type
Device
Intervention Name(s)
endovascular aneurysm repair (EVAR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
systolic maximum speed at the ostia of the renal arteries
Description
Quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of a suprarenal fixation aortic stent immediately postoperatively.
Time Frame
one month
Secondary Outcome Measure Information:
Title
systolic maximum speed at the ostia of the renal arteries
Description
Quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of a suprarenal fixation aortic stent immediately postoperatively.
Time Frame
one year
Title
proportion of patients with renal artery stenosis
Time Frame
one year
Title
proportion of disappearance of the "notch" (pre-systolic notch)
Time Frame
one year
Title
proportion of increase in systolic rise time
Time Frame
one year
Title
proportion of decrease of the resistance index
Time Frame
one year
Title
proportion of post-stenotic turbulence
Time Frame
one year
Title
glomerular filtration rate
Description
estimation of the glomerular filtration rate calculated by CKD-EPI between the preoperative and at one year
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Costa, doctor
Phone
0381668228
Email
pcosta@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie Salomon du Mont, doctor
Email
lsalomondumont@chu-besancon.fr
Facility Information:
Facility Name
Centre Hosptalier Universitaire
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Costa, doctor
Facility Name
Centre Hospitalier Universitaire
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric STEINMETZ, doctor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32358359
Citation
Salomon du Mont L, Parmentier AL, Puyraveau M, Mauny F, Guillon B, Rinckenbach S, Costa P. To assess hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of EVAR with a suprarenal fixation. Medicine (Baltimore). 2020 May;99(18):e19917. doi: 10.1097/MD.0000000000019917.
Results Reference
derived

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

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