Clinical trial NCT04724863: Analysis of Respiration-induced Deformities of the Visceral and Renal Arteries Before and After Stenting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Aortic Aneurysms
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* no contre indication for coroscanner

Exclusion Criteria:

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

Primary outcomes:
measure: Geometry of the visceral and renal branches
timeFrame: 1 day
Secondary outcomes:
measure: Endoleaks number
timeFrame: 3 months
measure: stenosis number
timeFrame: 3 months
Other outcomes:
Locations:
city: Le Plessis-Robinson
country: France
facility: Hopital Marie Lannelongue
Study officials:
affiliation: Hopital Marie Lannelongue
name: Stephan HAULON, Pr
role: STUDY_DIRECTOR
affiliation: Hopital Marie Lannelongue
name: Justine MOUGIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Marie Lannelongue
name: Olaf MERCIER, Pr
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.