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

Aortic Aneurysm Clinical Trial

Official title:

Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk by Computational Finite Element Analysis With Dedicated Software

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02800876
• Other study ID #: KEK-ZH-Nr. 2015-0156
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2016
• Last updated: June 10, 2016
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Exclusion Criteria:

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

• known pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

Other:
• CT-acquisition

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To calculated the rupture risk equivalent diameter (RRED) of the aortic aneurysm and rupture risk-index in the intraluminal thrombus within the aortic aneurysm.	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.	CT Data from 01/2004-12/2013	No