MedPath

Aortic Dynamics after Endovascular Aorta Repair

Recruiting
Conditions
Aneurysm
Aortic pathologies
10002363
Registration Number
NL-OMON49871
Lead Sponsor
Medisch Spectrum Twente
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

• Asymptomatic thoracic aortic pathology
• Age > 65 years
• Indication for aortic pathology treatment according to standard practise
• Anatomically suitability for one of the investigated grafts

Exclusion Criteria

No informed consent obtained
eGFR < 30 ml/min
Allergy for intra venous contrast fluid

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To gain insight in the parameters that influence the success and failure of the<br /><br>proximal fixation and/or sealing of Thoraflex Hybrid device and Relay(Branch)<br /><br>stent grafts.<br /><br><br /><br>More practically, this leads to the questions of how the diameter of the<br /><br>(proximal) stent rings changes during the cardiac cycle (pulsatility), how the<br /><br>diameter changes over a period of several months (expansion) and how the grafts<br /><br>interact with the dynamics of the stented target vessels.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>• How does the estimated vessel compliance change during follow-up?<br /><br>• Can we observe other kinds of motion that change over time?<br /><br>• What are the differences and similarities of thoracic endograft vs. thoracic<br /><br>hybrid graft (Relay(Branch) vs. Thoraflex Hybrid) considering:<br /><br>o Expansion?<br /><br>o Pulsatility?<br /><br>o Conformability to the native vessel?</p><br>
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