Changes in Renal Artery Movement Due to Respiration Before and After Fenestrated Endovascular Repair

NCT ID: NCT02266862

Last Updated: 2017-06-05

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-08-31

Brief Summary

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Purpose: The purpose of this study is to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. Then, the renal artery segment with maximal angular displacement on each will be located and any changes described.

Participants: There will be 30 subjects recruited from UNC Hospitals.

Procedures (methods): For this study, patients will receive an additional CT sequence (end-expiration CT), which will be compared with the standard of care end-inspiration CT to calculate angular displacement and the distance from the aorta.

Detailed Description

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The investigators would like to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. The investigators would then locate the renal artery segment with maximal angular displacement on each and describe any changes. Because these patients would be getting pre and post-surgical CTs as part of standard of care, there would be no added charge to obtain the information for the study. There would be, however, minimal increased radiation exposure resulting from the extra scan being performed during end-expiration and the patients would have to consent to the slight added risk to participate.

Conditions

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Fenestrated Endovascular Aortic Repair

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

The purpose of this study is to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair.

Study group

Intervention Type RADIATION

Patients will receive an additional CT sequence (end-expiration) at the time of their standard CT imaging before and after the repair.

Interventions

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Study group

Patients will receive an additional CT sequence (end-expiration) at the time of their standard CT imaging before and after the repair.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Undergoing pre-procedural CT scan for FEVAR

Exclusion Criteria

* Has aortic/renal stent already
* Cannot receive IV contrast due to renal insufficiency or allergy
* Renal arteries are not patent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ari Isaacson, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Other Identifiers

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14-2330

Identifier Type: -

Identifier Source: org_study_id

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