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.
Asymptomatic AAA,
Age > 65
Indication for AAA treatment according to standard practice
Anatomic suitability for the fenestrated Treo stent graft
No informed consent obtained
eGFR < 30 ml/min
Allergy for intra venous contrast fluid.
The study population consists of 25 patients with an abdominal aortic aneurysms to be treated with F-EVAR, aged \>65. The study population are patients from either Medisch Spectrum Twente (MST), Rijnstate Ziekenhuis, Jeroen Bosch Ziekenhuis, Amsterdam UMC, UMC Utrecht and Zuyderland Medisch Centrum.
Cohort
Prospective
CT scan
Diagnostic testECG-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.
Proportion of patients who experience treatment success.
Treatment success is defined as freedom from the following: Type I and III endoleak; stent graft migration; AAA enlargement; AAA rupture; conversion to open surgery; significant twists, kinks or obstruction; aneurysm-related patient death.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
