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

Withdrawn

• Conditions: Fenestrated Endovascular Aortic Repair
• Interventions: Radiation: Study group

• Registration Number: NCT02266862
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-17
• Study Start: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	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.

Primary Outcome Measures

Name	Time	Method
Change in angular displacement	Baseline, 6 months	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.