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

• Sponsor: Centre Chirurgical Marie Lannelongue (Other)
• Overall Status: Completed
• CT.gov ID: NCT04724863
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complex Aortic Aneurysms	Procedure: Angioscan	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 28, 2020
• Actual Primary Completion Date: Oct 21, 2020
• Actual Study Completion Date: Jan 21, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Protocol Each patient agreeing to participate in the study will be distributed in the protocol group and will receive an angioscan according to the protocol in pre-operative and at the usual post-operative check-up within 3 months after the operation. The usual procedure, foresees an angioscanner with injection of contrast product and the measurement of the images is performed during a deep breath. In order to obtain a complete respiratory cycle, the study procedure foresees in addition to the usual procedure, an image measurement during a deep exhalation.

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.

Outcome Measures

Primary Outcome Measures

1. Geometry of the visceral and renal branches [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 Outcome Measures

1. Endoleaks number [3 months]

2. stenosis number [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• no contre indication for coroscanner

Exclusion Criteria:

• pregnant woman

• allergy to iodinated contrast media

• vulnerable people

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Marie Lannelongue	Le Plessis-Robinson		France	92350

Sponsors and Collaborators

• Centre Chirurgical Marie Lannelongue

Investigators

• Study Director: Stephan HAULON, Pr, Hopital Marie Lannelongue
• Principal Investigator: Justine MOUGIN, Dr, Hopital Marie Lannelongue
• Study Chair: Olaf MERCIER, Pr, Hopital Marie Lannelongue

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Centre Chirurgical Marie Lannelongue
• ClinicalTrials.gov Identifier: NCT04724863
• Other Study ID Numbers: 2019-A02417-50
• First Posted: Jan 26, 2021
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm

Study Results

No Results Posted as of Jan 26, 2021