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

NCT07475260 | Not Yet Recruiting

• 2 other identifiers: SVF-TreoNL-009578 R027471
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 6

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  One year post procedure.

Study Arms (1)

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

Interventions

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.

Also known as: ECG and respiratory -gated CT scan, Double gated CT scan

Complex AAA Patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Twente: lead

Study Sites (6)

Rijnstate Ziekenhuis

Arnhem, Gelderland, 6815AD, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

Location

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

Location

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Zuyderland Medisch Centrum

Heerlen, 6419PC, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Tomography, X-Ray Computed; Electrocardiography

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Study Officials

• Robert H Geelkerken

  University of Twente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elke Hestermann

CONTACT

+31 (0)53 489 4537; e.hestermann@utwente.nl

Robert H Geelkerken

CONTACT

r.h.geelkerken@utwente.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 19, 2026

Record last verified: 2025-04

Locations

NL (6)