Analysis of Respiration-induced Deformities of the Visceral and Renal Arteries Before and After Stenting
Primary Purpose
Complex Aortic Aneurysms
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Angioscan
Sponsored by
About this trial
This is an interventional treatment trial for Complex Aortic Aneurysms
Eligibility Criteria
Inclusion Criteria:
- no contre indication for coroscanner
Exclusion Criteria:
- pregnant woman
- allergy to iodinated contrast media
- vulnerable people
Sites / Locations
- Hopital Marie Lannelongue
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Protocol
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Endoleaks number
stenosis number
Full Information
NCT ID
NCT04724863
First Posted
March 10, 2020
Last Updated
January 21, 2021
Sponsor
Centre Chirurgical Marie Lannelongue
1. Study Identification
Unique Protocol Identification Number
NCT04724863
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
October 21, 2020 (Actual)
Study Completion Date
January 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Aortic Aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Angioscan
Intervention Description
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 Outcome Measure Information:
Title
Geometry of the visceral and renal branches
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Endoleaks number
Time Frame
3 months
Title
stenosis number
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
no contre indication for coroscanner
Exclusion Criteria:
pregnant woman
allergy to iodinated contrast media
vulnerable people
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan HAULON, Pr
Organizational Affiliation
Hopital Marie Lannelongue
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Justine MOUGIN, Dr
Organizational Affiliation
Hopital Marie Lannelongue
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olaf MERCIER, Pr
Organizational Affiliation
Hopital Marie Lannelongue
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Marie Lannelongue
City
Le Plessis-Robinson
ZIP/Postal Code
92350
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26846442
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.
Results Reference
background
PubMed Identifier
28552169
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.
Results Reference
background
PubMed Identifier
29501401
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.
Results Reference
background
PubMed Identifier
25601499
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.
Results Reference
background
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Analysis of Respiration-induced Deformities of the Visceral and Renal Arteries Before and After Stenting
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