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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04724863
Enrollment
15
Registered
2021-01-26
Start date
2020-04-28
Completion date
2021-01-21
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Aortic Aneurysms

Brief summary

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.

Interventions

PROCEDUREAngioscan

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.

Sponsors

Centre Chirurgical Marie Lannelongue
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* no contre indication for coroscanner

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Geometry of the visceral and renal branches1 dayAn 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

MeasureTime frame
Endoleaks number3 months
stenosis number3 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026