SVF-Treo Study: Influence of Cardiac and Respiratory Pulsatility Deformation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Twente

About this trial

This is a national multicenter study with 25 patients with a complex AAA undergoing endovascular repair with the Fenestrated TREO™ stent graft. ECG and respiratory-gated CT scans will be performed pre-operatively, at discharge, after 6 months, and after 12 months follow up. If stent movement is still present in after 12 months, then another scan will be taken at 24 months. To include respiratory gated with the ECG-gated, patients will undergo ECG-gated CT scan during an inspiration breath-hold as well as an expiration breath-hold. This double gated CT scans will allow us to analyse the movement of the stent graft caused by the cardiac cycle and respiratory cycle.

The duration of this study is 2.5 years.

Eligibility criteria

Qualifiers

Asymptomatic AAA,

Age > 65

Indication for AAA treatment according to standard practice

Anatomic suitability for the fenestrated Treo stent graft

Disqualifiers

No informed consent obtained

eGFR < 30 ml/min

Allergy for intra venous contrast fluid.

Trial design

Treatments tested in this trial

  • CT scan

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators