Intravascular Ultrasound (IVUS) in Complex Aortic Endovascular Interventions

September 19, 2023 updated by: University Hospital Muenster

Prospective Register of Anatomical / Geometric Data Obtained by Intravascular Ultrasound (IVUS) Examinatio´n of Bridging Stent Grafts in Complex Aortic Interventions

The study aims to investigate the applicability of intravascular ultrasound (IVUS) in the endovascular therapy of juxta-, supra- and thoracoabdominal aortic aneurysms.

The focus of the study is on the intraoperative and postoperative evaluation of the geometric data of bridging stentgrafts in terms of patency, occurrence of stenosis and/or kinking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intravascular ultrasound (IVUS) is an already validated diagnostic method increasingly use in endovascular interventions. In contrast to conventional digital subtraction angiography (DSA), the IVUS provides in vivo real-time vessel images. Furthermore, its accuracy has been examined in histological studies, which could report of a good correlation regarding the vessel diameters (Jin ZG et al. Int J Cardiovasc Imaging. 2017 Feb; 33 (2): 153-160.).

Stenosis and/or kinkings of stents or stentgrafts as well as their fully expansion and morphology can be assessed with the use of IVUS.

The IVUS has already been used successfully in the context of endovascular treatment of infrarenal aortic aneurysms (Endovascular Aortic Repair or EVAR). Here, the IVUS has proven to be a valuable diagnostic instrument to examine the anatomy of the inserted stent grafts intraoperatively and to detect any abnormalities. In addition, the use of IVUS led to a significant reduction in the use of iodine-containing contrast media and radiation exposure as part of these complex endovascular interventions (Pecoraro F et al. Ann Vasc Surg. 2019 Apr; 56: 209-215.).

In the endovascular therapy of thoracoabdominal as well as suprarenal and juxtarenal aortic aneurysms, stent grafts with recesses (windows - Fenestrated EVAR or FEVAR) or side arms (branches - Branched EVAR or BEVAR) for the renovisceral vessels (truncus coeliacus, superior mesenteric artery and renal arteries) are implanted. In exceptional cases, the renovisceral vessels are supplied with stent grafts that are implanted in parallel to the aortic stent grafts (Chimney-Technique). These branches or windows are then connected to the corresponding target vessels via a bridging stent graft. The patency and anatomy of the bridging stent grafts are usually checked intraoperatively by angiography. The dynamics of the contrast agent flow and the X-ray images of the framework of the stent graft help in assessing their patency as well as the absence of structural problems.

The Computed Tomographic Angiography (CTA) is considered the gold standard as diagnostic method to assess the patency and anatomy of the stentgrafts postoperatively. This diagnostic method bares with it the exposure to relevant radiation dose as well as to contrast media. However, CTA scans do not provide in vivo real-time vessel images.

Furthermore, in case of pathological findings a new intervention may be necessary. The IVUS technique overcomes these issues due to its low invasiveness and its possible use during the index procedure. This can lead to the immediate identification of eventual structural problems of the bridging stent grafts which can jeopardize their patency and to correct them already during the index procedure.

The use of the IVUS during FEVAR, BEVAR and CHEVAR has already been implemented in our clinical routine. At our knowledge, a prospective collection of anatomical-geometric data by IVUS in complex endovascular treatments of complex aortic aneurysm has not been yet reported.

The aim of the current study is the retrospective evaluation of the anatomical-geometric data already collected by IVUS as well as the prospective collection of new data regarding the patency and anatomy of bridging stent grafts.

Study Type

Observational

Enrollment (Actual)

80

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 Locations

  • Denmark
      • Copenhagen, Denmark
        • Department of Vascular Surgery, Rigshopitalet
  • Germany
      • Münster, Germany
        • Klinik für Gefäßchirurgie, St. Franziskus-Hospital
      • Münster, Germany
        • Muenster University Hospital
  • Italy
      • Modena, Italy
        • Vascualar Surgery, Nocsae Nuovo Ospedale Civile di Baggiovara St. Agostiono Estense
      • Padua, Italy
        • Vascular and Endovascular Surgery Division, Padua University
  • Sweden
      • Upplands Väsby, Sweden
        • Division of Vascular Surgery, Uppsala University

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated by BEVAR/CHEVAR/FEVAR due to a thoracoabdominal aneurysm,

Description

Inclusion Criteria:

  • Age over 18 years
  • Elective or emergency treatment of an aortic aneurysm with a branched or fenestrated stent graft or with the aid of parallel stent grafts´(chimney)
  • Patient capable of giving informed consent

Exclusion Criteria:

  • Patients who are already participating in another study
  • child bearing or breast feeding females

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IVUS Group
Patients treated by BEVAR/CHEVAR/FEVAR due to a thoracoabdominal aneurysm.
Diagnostic test: IVUS control
Intravascular Control of the bridging stentgrafts during branched EVAR
Other Names:
  • Volcano Philips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bSG patency
Time Frame: 5 years
Patency of the bridging stentgraft
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometrical changes
Time Frame: 5 years
Geometrical changes of the bridging stentgrafts during follow-up
5 years

Collaborators and Investigators

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

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Alexander Oberhuber, University Hospital Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 22, 2020

Primary Completion (Actual)

May 22, 2022

Study Completion (Actual)

May 22, 2023

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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