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

March 16, 2026 updated by: Elke Hestermann, University of Twente

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Heerlen, Netherlands, 6419PC
        • Zuyderland Medisch Centrum
        • Contact:
        • Principal Investigator:
          • Lee Bouwman
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815AD
        • Rijnstate Ziekenhuis
        • Contact:
          • Michel M.P.J. Reijnen
        • Principal Investigator:
          • Michel M.P.J. Reijnen
    • North Brabant
      • 's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Jan Willem Hinnen
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105AZ
    • Overijssel
    • Utrecht
      • Utrecht, Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
        • Contact:
        • Principal Investigator:
          • Joost A vvan Herwaarden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Complex AAA Patients
The entire cohort consists of patients with an abdominal aortic aneurysm eligible for fenestrated endovascular aortic repair using a fenestrated Treo device.
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.

Other Names:
  • ECG and respiratory -gated CT scan
  • Double gated CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year post procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Twente

Investigators

  • Principal Investigator: Robert H Geelkerken, University of Twente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVF-Treo
  • NL-009578 R027471 (Other Identifier: Centrale Commissie Mensgebonden Onderzoek (CCMO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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