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

NCT ID: NCT03594786

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Aneurysm, Abdominal Endovascular Procedures Renal Artery Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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endovascular aneurysm repair (EVAR) arm

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

Group Type EXPERIMENTAL

endovascular aneurysm repair (EVAR)

Intervention Type 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.

Interventions

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endovascular aneurysm repair (EVAR)

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hosptalier Universitaire

Besançon, , France

Site Status RECRUITING

Centre Hospitalier Universitaire

Dijon, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Patricia Costa, doctor

Role: CONTACT

0381668228

Lucie Salomon du Mont, doctor

Role: CONTACT

Facility Contacts

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Patricia Costa, doctor

Role: primary

Eric STEINMETZ, doctor

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32358359 (View on PubMed)

Other Identifiers

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2017-A03047-46

Identifier Type: -

Identifier Source: org_study_id

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