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

NOT YET RECRUITING

NCT07475260

Sponsor: University of Twente

Summary

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.

Official title: Investigating the Influence of Cardiac and Respiratory Pulsatility Deformation on the Abdominal Aorta Before and After the Implantation of the Fenestrated TREO.

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

OBSERVATIONAL

Enrollment

25

Start Date

2026-04-01

Completion Date

2028-01-31

Last Updated

2026-03-19

Healthy Volunteers

No

Conditions

Abdominal Aortic Aneurysm Endovascular Abdominal Aortic Aneurysm Repair Fenestrated Endovascular Aortic Repair

Interventions

DIAGNOSTIC_TEST

CT scan

ECG-gated CT is a technique in which the ECG of the patient is measured during scanning. This can be used during scanning for instance to apply the most dose in the diastolic phase of the cardiac cycle (where motion is lowest), a technique known as prospective gating. In retrospective gating, the ECG is used to split the data in bins corresponding to a specific phase of the cardiac cycle, and creating one volumetric image per bin. To incorporate the respiratory cycle with the ECG-gated CT scan, an ECG-gated CT scan will be taken during inspirational breath-hold and during expiration breath-hold. Creating one CT scan with two phases, inspiration ECG-gated and an expiration ECG-gated scan. This is the technique that we will be using in this study; it allows us to study the temporal aspects of the data.

Locations (6)

Rijnstate Ziekenhuis

Arnhem, Gelderland, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

UMC Utrecht

Utrecht, Utrecht, Netherlands

Zuyderland Medisch Centrum

Heerlen, Netherlands

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