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Aortic Arch Aneurysm clinical trials

View clinical trials related to Aortic Arch Aneurysm.

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NCT ID: NCT06385379 Recruiting - Clinical trials for Aortic Arch Aneurysm

Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)

Start date: June 30, 2024
Phase: N/A
Study type: Interventional

A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)

NCT ID: NCT05896397 Recruiting - Clinical trials for Thoracoabdominal Aortic Aneurysm

European Aortic Data Collection Project

EADC
Start date: May 31, 2023
Phase:
Study type: Observational

The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices. The study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.

NCT ID: NCT05530304 Recruiting - Clinical trials for Aortic Arch Aneurysm

Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.

triple_branch
Start date: February 9, 2023
Phase:
Study type: Observational [Patient Registry]

Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.

NCT ID: NCT05421130 Active, not recruiting - Aortic Aneurysm Clinical Trials

Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair

Start date: May 2, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the SP-GRIPFLOW catheter (the catheter designed by Fuji Systems) is safe and how well it functions. The information from this research will be used to help decide if the device should be approved for sale in the European Union. The SP-GRIPFLOW catheter may not yet be used by investigators outside of the study. Through the study, FUJI will prove that the target flow as measured by the flow through the catheter(s)(cumulative flow for multiple catheters) was confirmed in 95% of cases.

NCT ID: NCT04909190 Completed - Stroke Clinical Trials

Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System

SAFRANE
Start date: June 10, 2021
Phase: N/A
Study type: Interventional

Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. standard IFU-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after EVAR.

NCT ID: NCT04833283 Completed - Surgery Clinical Trials

The Effects of Intermittent Hypoxic-hyperoxic Preconditioning for Patients Undergoing Cardiopulmonary Bypass.

Start date: January 25, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effects of intermittent hypoxic-hyperoxic training (IHHT) to protect myocardium against perioperative myocardial injury during cardiac surgery using cardiopulmonary bypass.

NCT ID: NCT04809896 Completed - Clinical trials for Aortic Arch Aneurysm

Homemade Fenestrated Physician-modified Stent-grafts for Arch Aortic Degenerative Aneurysm

Start date: January 1, 2020
Phase:
Study type: Observational

The aim was to evaluate early and medium-term outcomes of single and double fenestrated physician-modified endovascular grafts (PMEGs) for endovascular aortic arch degenerative aneursym repair. The evolution of stent-graft technology recently has meant the development of custom-made branched stent-grafts to achieve total endovascular aortic arch repair for high-risks patients. The disadvantages of custom-made include manufacture and deliver times for urgent cases and the associated high costs. Unfortunately there is also a high rate of embolization associated with this approach probably related to the complexity of deploying a multi-branched unibody stent-graft. A further alternative is physician modified endografts (PMEGs) for zone 0 TEVAR involving the deployment of a conventional stent-graft device ex-vivo, fashioning of customized fenestrations (for supra aortic trunk) and re-constrainment into the delivery system. The authors have previously shown the feasability in vitro and they have reported their experience for arch aortic lesion. The aim of this study is to evaluate the outcomes for aortic arch degenerative aneursym repair which is the most risky procedure

NCT ID: NCT04765592 Active, not recruiting - Clinical trials for Aortic Arch Aneurysm

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)

Start date: June 7, 2021
Phase: N/A
Study type: Interventional

A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/false aortic arch aneurysms and ulcers involving aortic arch . (GIANT Study)

NCT ID: NCT04489277 Completed - Clinical trials for Aortic Arch Aneurysm

Silent Brain Infarction After Endovascular Arch Procedures

Start date: September 1, 2018
Phase:
Study type: Observational [Patient Registry]

This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral embolization.

NCT ID: NCT04244188 Completed - Clinical trials for Aortic Arch Aneurysm

Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

Start date: January 1, 2019
Phase:
Study type: Observational

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.