SVF-Treo Study: Influence of Cardiac and Respiratory Pulsatility Deformation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT scan.
- Who it may be relevant to
- Registry conditions: Abdominal Aortic Aneurysm, Endovascular Abdominal Aortic Aneurysm Repair, Fenestrated Endovascular Aortic Repair. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigating the Influence of Cardiac and Respiratory Pulsatility Deformation on the Abdominal Aorta Before and After the Implantation of the Fenestrated TREO.
Overview
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.
Detailed description
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.
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,
Primary outcome measures
- Proportion of patients who experience treatment success. [Time frame: One year post procedure.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 6 centers
- Rijnstate Ziekenhuis — Arnhem
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch
- Amsterdam UMC — Amsterdam
- Medisch Spectrum Twente — Enschede
- UMC Utrecht — Utrecht
- Zuyderland Medisch Centrum — Heerlen
Identifiers
NCT: NCT07475260 · SVF-Treo · NL-009578 R027471