- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04724863
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Le Plessis-Robinson, France, 92350
- Hopital Marie Lannelongue
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- no contre indication for coroscanner
Exclusion Criteria:
- pregnant woman
- allergy to iodinated contrast media
- vulnerable people
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometry of the visceral and renal branches
Time Frame: 1 day
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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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Endoleaks number
Time Frame: 3 months
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3 months
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stenosis number
Time Frame: 3 months
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3 months
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Collaborators and Investigators
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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A02417-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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