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Completed

NCT Number: NCT04724863

Analysis of Respiration-induced Deformities of the Visceral and Renal Arteries Before and After Stenting

Fenestrated stents are used for the management of complex juxta-renal, para-renal or thoracoabdominal aneurysms in patients with high surgical risk and/or contraindicated for open surgery. These endovascular techniques have demonstrated their safety and efficacy, however, long-term follow-up CT scans remain essential for the detection of complications such as endo-leaks and restenosis/thrombosis of visceral and renal stents. The respiratory cycle might induce changes in the geometry and deformations of visceral and renal stents after complex aortic procedures. These could be detected by an adapted CT scan analysis by deep inhalation and deep exhalation acquisition carried out pre-operatively and post-operatively for monitoring of these same stents and screening for complications.

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Key information

Conditions

Complex Aortic Aneurysms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no contre indication for coroscanner

Exclusion criteria

  • pregnant woman
  • allergy to iodinated contrast media
  • vulnerable people

Treatment and study plan

Angioscan

Procedure

The study procedure foresees to take images during a deep breath as well as deep exhalation. This second measurement does not require the administration of an additional amount of contrast material. However, the exposure time to ionising radiation is doubled. The examination uses helical acquisition in fast mode. The duration of the helix is of the order of 2 seconds in the inspiration phase, then there is a delay of 5 seconds of machine time ("half-turn") and again 2 seconds of exposure in the expiration phase, i.e. 4 seconds of actual exposure to ionizing radiation, the time of image taking and 9 seconds the total time of the examination.

Primary outcomes

  1. Geometry of the visceral and renal branches

    Time frame: 1 day

    An angioscanner will be performed with injection in inspiration and expiration (breathing cycle) before and after stent placement for a fenestrated aortic endografts.

    After reconstruction of a 3D volume of the aorta and extraction of the central lines of the different target arteries, the angle of the different visceral and renal branches will be measured during the respiratory cycle (inspiration; expiration) and compared before and after stenting.

Secondary outcomes

  1. Endoleaks number

    Time frame: 3 months

  2. stenosis number

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Centre Chirurgical Marie Lannelongue

Other

Registry information

Official study title

Analysis of Respiration-induced Deformities of the Visceral and Renal Arteries Before and After Stenting for a Endovascular Aortic Repair Procedure Using a Fenestrated Prothesis

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 26, 2021
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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