Abdominal Aortic AneurysmSVF-TreoNCT07475260
SVF-Treo Study: Influence of Cardiac and Respiratory Pulsatility Deformation
An observational study of Abdominal Aortic Aneurysm and Endovascular Abdominal Aortic Aneurysm Repair, run by University of Twente at 6 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Endovascular Abdominal Aortic Aneurysm Repair, Fenestrated Endovascular Aortic Repair
- What is being tested?
- CT scan
- How many people
- 25 participants
- Where
- 6 sitesNetherlands
- Study dates
- 1 Apr 2026to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- No informed consent obtained
- eGFR < 30 ml/min
- Allergy for intra venous contrast fluid.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Robert H Geelkerken contact
6 sites in 1 country
Netherlands6 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5223 GZ
Jan Willem Hinnen, j.hinnen@jbz.nl
Jan Willem Hinnen
Amsterdam UMC
Amsterdam, North Holland, 1105AZ
Kak Khee Yeung, k.yeung@amsterdamumc.nl
Kak Khee Yeung
Rijnstate Ziekenhuis
Arnhem, Gelderland, 6815AD
Michel M.P.J. Reijnen
Michel M.P.J. Reijnen
Medisch Spectrum Twente
Enschede, Overijssel, 7512KZ
Robert H Geelkerken, r.geelkerken@mst.nl
Anja Stam, researchbureau.heelkunde@mst.nl
Zuyderland Medisch Centrum
Heerlen, 6419PC
Lee Bouwman, l.bouwman@zuyderland.nl
Lee Bouwman
UMC Utrecht
Utrecht, Utrecht, 3584 CX
Joost A van Herwaarden, j.a.vanherwaarden@umcu.nl
Joost A vvan Herwaarden
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm, Endovascular Abdominal Aortic Aneurysm Repair, Fenestrated Endovascular Aortic Repair
- Being tested
- CT scan
- Keywords
- Abdominal Aortic Aneurysm, Endovascular Aneurysm Repair, FEVAR, Computed Tomography Imaging, CT, ECGgated
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
Also called ECG and respiratory -gated CT scan, Double gated 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elke Hestermann, University of Twente
- Investigators
- Robert H Geelkerken, Principal investigator, University of Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475260
- Sponsor's protocol ID
- SVF-Treo
- Other IDs
- NL-009578 R027471
- Acronym
- SVF-Treo
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Influence of Cardiac and Respiratory Pulsatility Deformation on the Abdominal Aorta Before and After the Implantation of the Fenestrated TREO.
- ClinicalTrials.gov ID
- NCT07475260
- Acronym / sponsor ID
- SVF-Treo / SVF-Treo
- Conditions
- Abdominal Aortic Aneurysm, Endovascular Abdominal Aortic Aneurysm Repair, Fenestrated Endovascular Aortic Repair
- Keywords
- Abdominal Aortic Aneurysm, Endovascular Aneurysm Repair, FEVAR, Computed Tomography Imaging, CT, ECGgated
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of TwenteUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complex AAA Patients | – | Diagnostic Test: CT scanThe entire cohort consists of patients with an abdominal aortic aneurysm eligible for fenestrated endovascular aortic repair using a fenestrated Treo device. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- No informed consent obtained
- eGFR < 30 ml/min
- Allergy for intra venous contrast fluid.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanAlso: ECG and respiratory -gated CT scan, Double gated CT scanECG-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. | Diagnostic test | Complex AAA Patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert H Geelkerken contact
Robert H Geelkerken principal investigator
University of Twente
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Endovascular Abdominal Aortic Aneurysm Repair, run by University of Twente at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elke Hestermann (+31 (0)53 489 4537, e.hestermann@utwente.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who experience treatment success. (time frame: One year post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.