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bTEVAR stroke

A pilot study on the cause of recurring cerebral thrombo-embolic events after Branched Thoracic Endovascular Aneurysm Repair - bTEVAR stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57443
Enrollment
4
Registered
2025-01-22
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aneurysmata Cerebral thrombo-embolism Stroke

Interventions

For the retrospective part of this study, ECG-gated CT scans will be gathered from the hospital databases for all four patients. &nbsp
For the prospective part of this study, 4D-flow MRI and blood Speckle Tracking measurements will be performed on the three patients from the Radboud hospital. The MRI scans will be performed at the Te

Sponsors

Universiteit Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient with complications after bTEVAR, Medisch Spectrum Twente: History of thoracic abdominal aneurysm in thoracic branch of aorta, either treated by bTEVAR with a Terumo Aortic Relay ® Branch endoprosthesis in situ or scheduled to be treated using this deviceRecurrent cerebral thrombo-embolic events during follow-up after bTEVAR-surgery.;Able to provide informed consent.  Patients without complications after bTEVAR, Radboudumc:History of thoracic abdominal aneurysm in thoracic branch of aorta, either treated by bTEVAR with a Terumo Aortic Relay ® Branch endoprosthesis in situ or scheduled to be treated using this device.;No cerebral thrombo-embolic events during follow-up after bTEVAR-surgery.;Willingness to undergo MRI scans and blood Speckle Tracking measurements.;Able to provide informed consent. 

Exclusion criteria

Exclusion criteria: Irregular heartbeat.;Depth of carotid artery too large (distance to skin > 3.5 cm);The standard MRI exclusion criteria (such as pacemakers, cerebral vascular  clips, pregnancy, claustrophobia etc.).

Design outcomes

Primary

MeasureTime frame
This study will yield a workflow for investigating blood flow in carotid arteries and stented aortic arch region of patients who suffered from recurring thrombo-embolic events after stentgraft placement (bTEVAR) using two imaging techniques. Blood flow will be investigated using 4D-flow MRI and blood Speckle tracking. Flow boundary conditions in the carotid arteries (blood Speckle Tracking) and aortic arch, including branched arteries such as subclavian arteries, common carotid artery and visceral branch vessels (4D-flow MRI) will be investigated. This will be analysed in the form of volumetric flow rates and velocity fields, besides the regular anatomical scans. Other quantitative parameters, such as wall shear stress and residence time, will be investigated as well.Qualitative and quantitative data will be compared between a patient with recurring thrombo-embolic events after bTEVAR and patients without complications. In this study this comparison will be done between in in-vitro and in-silico models (see secondary objectives) of a patient who suffered from recurring strokes after bTEVAR and a patient who did not suffer from these complications. Applying this technique in-vivo on patients who suffered from multiple strokes will be topic of a new clinical study in the future. This way, conclusions might be drawn on any flow patterns that are unfavourable for developing thrombus and thrombo-embolic events. The parameters obtained from the in-vivo 4D-flow MRI and bST measurements performed in this study will be used to tune the in-vitro and in-silico models to mimic the mechanical properties of the aortic wall as accurately as possible. 

Secondary

MeasureTime frame
Measure stentgraft deformation over the cardiac cycle – based on retrospectively obtained ECG-gated CT angiography (CTA) scans – using an in-house analysis algorithm and relate this to the observed flow patterns.;Assess the feasibility of non-contrast-enhanced 4D-flow MRI for measuring flow in stented human aortas and stented in-vitro models. This includes assessing the impact of metal artefacts caused by the stentgrafts on image quality and flow measurements.;Optimise the MRI signal-to-noise ratio by testing out a sequence with a higher resolution and smaller field-of-view for the visceral branches (carotid arteries, subclavian arteries) and a sequence with a coarser resolution and larger field-of-view for the main aortic arch.;Test the feasibility of simultaneously performing electrocardiogram (ECG) triggering and respiratory triggering during the MRI scans.;Translate the ECG-gated CTA scans from the patient with cerebral thrombo-embolic events and one patient without complications into physical models (phantom) by 3D-printing for a more detailed study of blood flow patterns and stentgraft deformation. In these models, perform 4D-flow MRI and Echo-PIV with varying flow inlet conditions to study the blood flow.Translate the ECG-gated CTA scans and 4D-MRI scans from the patient with cerebral thrombo-embolic events and one patient without complications into in-silico models in which more advanced Computational Fluid Dynamics can be performed. Compare the results of in-vitro and in-silico flow experiments in complicated and uncomplicated patient models. 

Countries

Netherlands

Contacts

Public ContactM.E. Krommendijk

Universiteit Twente

m.e.krommendijk@utwente.nl+31534894988

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 29, 2026