Clinical trial NCT04663074: Intravascular Ultrasound (IVUS) in Complex Aortic Endovascular Interventions
Official title: Prospective Register of Anatomical / Geometric Data Obtained by Intravascular Ultrasound (IVUS) Examinatio´n of Bridging Stent Grafts in Complex Aortic Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Aortic Aneurysm
Keywords: Intravascular ultrasound
bridging stentgraft
BEVAR
EVAR
IVUS
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by BEVAR/CHEVAR/FEVAR due to a thoracoabdominal aneurysm,

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: bSG patency
timeFrame: 5 years
Secondary outcomes:
measure: Geometrical changes
timeFrame: 5 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Vascular Surgery, Rigshopitalet
city: Münster
country: Germany
facility: Klinik für Gefäßchirurgie, St. Franziskus-Hospital
city: Münster
country: Germany
facility: Muenster University Hospital
city: Modena
country: Italy
facility: Vascualar Surgery, Nocsae Nuovo Ospedale Civile di Baggiovara St. Agostiono Estense
city: Padua
country: Italy
facility: Vascular and Endovascular Surgery Division, Padua University
city: Upplands Väsby
country: Sweden
facility: Division of Vascular Surgery, Uppsala University
Study officials:
affiliation: University Hospital Muenster
name: Alexander Oberhuber
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pecoraro F, Bracale UM, Farina A, Badalamenti G, Ferlito F, Lachat M, Dinoto E, Asti V, Bajardi G. Single-Center Experience and Preliminary Results of Intravascular Ultrasound in Endovascular Aneurysm Repair. Ann Vasc Surg. 2019 Apr;56:209-215. doi: 10.1016/j.avsg.2018.09.016. Epub 2018 Nov 27.
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