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NCT Number: NCT07475260

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

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.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Endovascular Abdominal Aortic Aneurysm Repair Fenestrated Endovascular Aortic Repair Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate Ziekenhuis, Arnhem, Gelderland, Netherlands

About this study

Fenestrated endovascular aortic repair (F-EVAR) uses stent grafts with customized fenestrations to treat complex aortic aneurysms in patients at risk of aneurysm rupture. The long-term durability of these stent grafts is hindered by complications requiring reintervention. Especially the perirenal fixation and sealing area is of vital importance. The customized fenestrations in the stent graft are cannulated with stents into the renal and/or mesenteric arteries, challenging the perirenal fixation. Once implanted, the aorta dynamics and the device affect each other in ways that are currently not understood. Pre and post- operative imaging of aortic aneurysm is routinely performed using computerized tomographic angiography (CTA). However, these static techniques do not consider the aorta dynamics. Consequently, our understanding of the dynamic behavior of the stent graft and stented target vessels is limited. ECG-gated CTA is a technique that takes the patient's heart cycle into account and taking the ECG-gated CTA during inspiration and during expiration takes the patients respiratory motion into account, creating a double gated CT scan. This double gated CTA enables studying the motion of aorta and implanted devices.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Asymptomatic AAA,
Age > 65
Indication for AAA treatment according to standard practice
Anatomic suitability for the fenestrated Treo stent graft
At least one stentable main renal artery and one other stentable renal or mesenteric artery
Being able to hold their breath for 10 seconds.

Exclusion criteria

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

Treatment and study plan

CT Scan

Diagnostic Test

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.

Other names: ECG and respiratory -gated CT scan, Double gated CT scan

Primary outcomes

Proportion of patients who experience treatment success.

Time frame: One year post procedure.

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elke Hestermann

CONTACT

[email protected]

+31 (0)53 489 4537

Robert H Geelkerken

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Twente

Other

Registry information

Official study title

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

Acronym: SVF-Treo

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Mar 16, 2026
Registry last updated: Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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