Clinical Trials Logo

Clinical Trial Summary

Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, the investigators aim is to develop a computational tool able to predict SG deployment in such highly complex situations. Four patient-specific cases will be performed with complete deployment of the DB and its bridging stents in aneurysmal aortic arch. Deviations of simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. If good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the DB deployment in complex anatomy. The results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.


Clinical Trial Description

The process of numerical simulation of double-branched device in aortic arch aneurysm involves: (i) aortic arch segmentation with data from the preoperative CT-scan (ii) numerical modeling of the actual stentgraft used to treat the patient (iii) simulation of stentgraft deployment in aortic arch (iv) validation of simulation results based on post-operative CT scan images The goal of this study is to develop a numerical model of stentgraft deployment able to predict the actual deployement of the double branched device in aortic arch aneurysm. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04244188
Study type Observational
Source Centre Hospitalier Universitaire de Saint Etienne
Contact
Status Completed
Phase
Start date January 1, 2019
Completion date January 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT04489277 - Silent Brain Infarction After Endovascular Arch Procedures
Recruiting NCT03347812 - Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair N/A
Recruiting NCT05896397 - European Aortic Data Collection Project
Active, not recruiting NCT05421130 - Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair N/A
Recruiting NCT02050113 - Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices N/A
Recruiting NCT02089607 - Complex Abdominal, TAAA, Aortic Arch Aneurysm or Dissections With Fenestrated/Branched Stent Graft N/A
Active, not recruiting NCT04765592 - Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study) N/A
Completed NCT04909190 - Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System N/A
Enrolling by invitation NCT01654133 - Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair Using Branched Stent- Grafts N/A
Completed NCT04833283 - The Effects of Intermittent Hypoxic-hyperoxic Preconditioning for Patients Undergoing Cardiopulmonary Bypass. N/A
Recruiting NCT01524211 - Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms N/A
Completed NCT04809896 - Homemade Fenestrated Physician-modified Stent-grafts for Arch Aortic Degenerative Aneurysm
Recruiting NCT05530304 - Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.
Completed NCT03420066 - The NEXUS™ Compassionate Use Data Collection Study
Recruiting NCT06385379 - Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study) N/A