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

Complex Aortic Aneurysms Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724863
• Other study ID #: 2019-A02417-50
• Status: Completed
• Phase: N/A
• Start date: April 28, 2020
• Est. completion date: January 21, 2021

Study information

• Verified date: January 2021
• Source: Centre Chirurgical Marie Lannelongue
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 21, 2021
• Est. primary completion date: October 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• no contre indication for coroscanner

Exclusion Criteria:

• pregnant woman

• allergy to iodinated contrast media

• vulnerable people

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Complex Aortic Aneurysms

Intervention

Procedure:
• Angioscan
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.

Locations

Country	Name	City	State
France	Hopital Marie Lannelongue	Le Plessis-Robinson

Sponsors (1)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

References & Publications (4)

Eagleton MJ, Farivar B, Dias A. Large, single-center databases and the evolution of endovascular therapy for complex aortic aneurysms. Surgery. 2017 Nov;162(5):963-973. doi: 10.1016/j.surg.2017.03.018. Epub 2017 May 25. Review. — View Citation

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. — View Citation

Ullery BW, Suh GY, Lee JT, Liu B, Stineman R, Dalman RL, Cheng CP. Geometry and respiratory-induced deformation of abdominal branch vessels and stents after complex endovascular aneurysm repair. J Vasc Surg. 2015 Apr;61(4):875-84. doi: 10.1016/j.jvs.2014.11.075. Epub 2015 Jan 15. — View Citation

Yaoguo Y, Zhong C, Lei K, Yaowen X. Treatment of complex aortic aneurysms with fenestrated endografts and chimney stent repair: Systematic review and meta-analysis. Vascular. 2017 Feb;25(1):92-100. doi: 10.1177/1708538115627718. Epub 2016 Jul 10. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometry of the visceral and renal branches	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.	1 day
Secondary	Endoleaks number		3 months
Secondary	stenosis number		3 months