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

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.

Study Overview

• Status: Withdrawn
• Conditions: Fenestrated Endovascular Aortic Repair
• Intervention / Treatment: Radiation: Study group

Detailed Description

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with fenestrated endovascular aortic repair (FEVAR) will be included in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Radiation: Study group; Patients will receive an additional CT sequence (end-expiration) at the time of their standard CT imaging before and after the repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in angular displacement	We will calculate the distance from the aorta and angular displacement both before and after the procedure. Then, a paired t-test will be used to compare these values to determine statistical significance.	Baseline, 6 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Ari Isaacson, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): June 5, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 14-2330