Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair

NCT01843335 | Terminated

• 1 other identifier: 2013/359/REKnord
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate information about endoleak after EVAR. Benefits of CEUS over CT include less radiation exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent application and decrease in the cost of EVAR follow-up. This study is designed to investigate if results from literature are reproducible in St Olavs Hospital in Trondheim (Norway), to gain experience with the technique and to introduce CEUS as an alternative for detection of endoleak in this hospital.

Conditions

Abdominal Aortic Aneurysm; Endoleak

Keywords

Cardiovascular Diagnostic Technique; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Detection of endoleak with CEUS

  Compare CEUS with computed tomography angiography (CTA) sensitivity for detection of endoleak

  9 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in follow-up after endovascular implantation of abdominal aortic prothesis, Central Norway

You may qualify if:

• in follow-up after endovascular implantation of abdominal aortic prothesis

You may not qualify if:

• None

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• SINTEF Health Research: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Endoleak

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Reidar Brekken, PhD

  National Taiwan Normal University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: April 30, 2013
• Study Start: September 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

NO (1)