• Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA

  NCT07026877

  RecruitingInterventionalNot ApplicableUpdated Feb 18, 2026
• Post-Approval Study of the TREO Abdominal Stent-Graft System

  NCT04697784

  Active, not recruitingInterventionalNot ApplicableUpdated Jun 26, 2025
• Analysis of Respiration-induced Deformities of the Visceral and Renal Arteries Before and After Stenting

  NCT04724863

  CompletedInterventionalNot ApplicableUpdated Jan 26, 2021
• Changes in Renal Artery Movement Due to Respiration Before and After Fenestrated Endovascular Repair

  NCT02266862

  WithdrawnObservationalUpdated Jun 5, 2017
• An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft

  NCT03187522

  TerminatedInterventionalNot ApplicableUpdated Mar 3, 2021
• Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial

  NCT00281411

  CompletedObservationalUpdated Feb 15, 2018

ClinicalTrials.gov ID

NCT07475260

Lead Sponsor

University of TwenteOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

25Estimated

Last Update Posted

Mar 19, 2026Actual

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Jan 31, 2028Estimated

Official Title

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

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.

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.

• Abdominal Aortic Aneurysm
• Endovascular Abdominal Aortic Aneurysm Repair
• Fenestrated Endovascular Aortic Repair

• CT scan

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University of TwenteOTHER

k.yeung@amsterdamumc.nl

j.a.vanherwaarden@umcu.nl

l.bouwman@zuyderland.nl