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

NCT02266862 | Withdrawn

• 1 other identifier: 14-2330
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fenestrated Endovascular Aortic Repair

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Study group RADIATION

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

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Undergoing pre-procedural CT scan for FEVAR

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Officials

• Ari Isaacson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 17, 2014
• Study Start: August 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 5, 2017

Record last verified: 2017-05