NCT04663074

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2023

Completed
Last Updated

September 21, 2023

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

December 3, 2020

Last Update Submit

September 19, 2023

Conditions

Thoracic Aortic Aneurysm

Keywords

Intravascular ultrasoundbridging stentgraftBEVAREVARIVUS

Outcome Measures

Primary Outcomes (1)

  • bSG patency

    Patency of the bridging stentgraft

    5 years

Secondary Outcomes (1)

  • Geometrical changes

    5 years

Study Arms (1)

IVUS Group

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

Diagnostic Test: IVUS control

Interventions

IVUS controlDIAGNOSTIC_TEST

Intravascular Control of the bridging stentgrafts during branched EVAR

Also known as: Volcano Philips
IVUS Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Vascular Surgery, Rigshopitalet

Copenhagen, Denmark

Location

Klinik für Gefäßchirurgie, St. Franziskus-Hospital

Münster, Germany

Location

Muenster University Hospital

Münster, Germany

Location

Vascualar Surgery, Nocsae Nuovo Ospedale Civile di Baggiovara St. Agostiono Estense

Modena, Italy

Location

Vascular and Endovascular Surgery Division, Padua University

Padua, Italy

Location

Division of Vascular Surgery, Uppsala University

Upplands Vasby, Sweden

Location

Related Publications (9)

  • Jin ZG, Zhang ZQ, Jing LM, Wei YJ, Zhang J, Luo JP, Yang SL, Ma DX, Liu Y, Han W, Yang Y, Liu HL. Correlation between dual-axis rotational coronary angiography and intravascular ultrasound in a coronary lesion assessment. Int J Cardiovasc Imaging. 2017 Feb;33(2):153-160. doi: 10.1007/s10554-016-0999-5. Epub 2016 Oct 11.

    PMID: 27730313BACKGROUND

  • 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.

    PMID: 30500656BACKGROUND

  • Georgiadis GS, van Herwaarden JA, Antoniou GA, Hazenberg CE, Giannoukas AD, Lazarides MK, Moll FL. Systematic Review of Off-the-Shelf or Physician-Modified Fenestrated and Branched Endografts. J Endovasc Ther. 2016 Feb;23(1):98-109. doi: 10.1177/1526602815611887. Epub 2015 Oct 23.

    PMID: 26496957BACKGROUND

  • Mafeld S, Annamalai G, Lindsay TF, Zhong I, Tarulli E, Mironov O, Tan KT. Initial Experience With Viabahn VBX as the Bridging Stent Graft for Branched and Fenestrated Endovascular Aneurysm Repair. Vasc Endovascular Surg. 2019 Jul;53(5):395-400. doi: 10.1177/1538574419840880. Epub 2019 Apr 24.

    PMID: 31018828BACKGROUND

  • Spear R, Sobocinski J, Hertault A, Delloye M, Azzauiu R, Fabre D, Haulon S. One Year Outcomes of 101 BeGraft Stent Grafts used as Bridging Stents in Fenestrated Endovascular Repairs. Eur J Vasc Endovasc Surg. 2018 Apr;55(4):504-510. doi: 10.1016/j.ejvs.2018.01.023. Epub 2018 Mar 1.

    PMID: 29501401BACKGROUND

  • Donas KP, Lee JT, Lachat M, Torsello G, Veith FJ; PERICLES investigators. Collected world experience about the performance of the snorkel/chimney endovascular technique in the treatment of complex aortic pathologies: the PERICLES registry. Ann Surg. 2015 Sep;262(3):546-53; discussion 552-3. doi: 10.1097/SLA.0000000000001405.

    PMID: 26258324BACKGROUND

  • Timaran DE, Knowles M, Soto-Gonzalez M, Modrall JG, Tsai S, Kirkwood M, Rectenwald J, Timaran CH. Gender and perioperative outcomes after fenestrated endovascular repair using custom-made and off-the-shelf devices. J Vasc Surg. 2016 Aug;64(2):267-272. doi: 10.1016/j.jvs.2016.02.062. Epub 2016 Jun 15.

    PMID: 27316411BACKGROUND

  • Verhoeven EL, Katsargyris A, Oikonomou K, Kouvelos G, Renner H, Ritter W. Fenestrated Endovascular Aortic Aneurysm Repair as a First Line Treatment Option to Treat Short Necked, Juxtarenal, and Suprarenal Aneurysms. Eur J Vasc Endovasc Surg. 2016 Jun;51(6):775-81. doi: 10.1016/j.ejvs.2015.12.014. Epub 2016 Feb 6.

    PMID: 26860255BACKGROUND

  • Mastracci TM, Carrell T, Constantinou J, Dias N, Martin-Gonzalez T, Katsargyris A, Modarai B, Resch T, Verhoeven EL, Burnell M, Haulon S. Editor's Choice - Effect of Branch Stent Choice on Branch-related Outcomes in Complex Aortic Repair. Eur J Vasc Endovasc Surg. 2016 Apr;51(4):536-42. doi: 10.1016/j.ejvs.2015.12.046. Epub 2016 Feb 23.

    PMID: 26916389BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Alexander Oberhuber

    University Hospital Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 10, 2020

Study Start

May 22, 2020

Primary Completion

May 22, 2022

Study Completion

May 22, 2023

Last Updated

September 21, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)DE(2)DK(1)IT(2)