NCT03594786

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 11, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

April 24, 2018

Last Update Submit

March 9, 2020

Conditions

Aortic Aneurysm, AbdominalEndovascular ProceduresRenal Artery Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • systolic maximum speed at the ostia of the renal arteries

    one year

  • proportion of patients with renal artery stenosis

    one year

  • proportion of disappearance of the "notch" (pre-systolic notch)

    one year

  • proportion of increase in systolic rise time

    one year

  • proportion of decrease of the resistance index

    one year

  • +2 more secondary outcomes

Study Arms (1)

endovascular aneurysm repair (EVAR) arm

EXPERIMENTAL

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

Device: endovascular aneurysm repair (EVAR)

Interventions

endovascular aneurysm repair (EVAR)DEVICE

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.

endovascular aneurysm repair (EVAR) arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hosptalier Universitaire

Besançon, France

RECRUITING

Centre Hospitalier Universitaire

Dijon, France

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 32358359DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalRenal Artery Obstruction

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Central Study Contacts

Patricia Costa, doctor

CONTACT

0381668228pcosta@chu-besancon.fr

Lucie Salomon du Mont, doctor

CONTACT

lsalomondumont@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

July 20, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2021

Last Updated

March 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)