Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk

• Conditions: Aortic Aneurysm
• Interventions: Other: CT-acquisition

• Registration Number: NCT02800876
• Lead Sponsor: University of Zurich

Brief Summary

Retrospective study to evaluate the impact of computational wall stress analysis based on computed tomography (CT) of ruptured and not-ruptured aortic aneurysms as an additional predictor for rupture with dedicated software.

Detailed Description

In patients with known aortic aneurysm who received clinically indicated CT during a time period from 01/2004-12/2013 the CT data was evaluated with dedicated software, A4clinics, VASCOPS GmbH, Graz, Austria. The following parameters will be evaluated: exterior and luminal diameter, intraluminal thrombus (ILT) thickness, vessel-, luminal- and intraluminal thrombus volume, peak wall stress (PWS), peak wall rupture risk (PWRR), von Mises-stress and rupture risk-index in the ILT.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-06
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-10
• Last Update Submitted: 2016-06-10
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-15
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Clinical indicated CT data from patients with known aortic aneurysms.

Clinical indication was:

• Follow up CT examination by known aortic aneurysm
• Patient with known aortic aneurysm with new acute clinical symptoms
• Patients with clinical suspicion of aortic aneurysm

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Exclusion Criteria

• known exclusion criteria for CT examination as known allergy to iodine or contrast media
• known pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
asymptomatic not ruptured aneurysm	CT-acquisition	Patients with asymptomatic not ruptured aortic aneurysms greater than 3 cm who received a clinical indicated CT
symptomatic ruptured aneurysm	CT-acquisition	Patients with symptomatic ruptured aortic aneurysms greater than 3 cm who received a clinical indicated CT
patients with small aneurysms	CT-acquisition	Patients with small aortic aneurysms approximately 5.5 cm, ruptured and not ruptured, who received a clinical indicated CT
symptomatic not ruptured aneurysm	CT-acquisition	Patients with symptomatic aortic aneurysms greater than 3 cm who received a clinical indicated CT

Primary Outcome Measures

Name	Time	Method
To calculated the rupture risk equivalent diameter (RRED) of the aortic aneurysm and rupture risk-index in the intraluminal thrombus within the aortic aneurysm.	CT Data from 01/2004-12/2013	By using the finite analysis from the CT data the peak wall stress (PWS), the peak wall rupture (PWRR) and the mises stress within the aortic aneurysm depending on the diameter and volume of the aortic aneurysm and of the intraluminal thrombus will be measured.

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland