Valiant Evo International Clinical Trial

Status Completed

Clinical Trial Summary

The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.

Clinical Trial Description

Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 total subjects, in order obtain 87 evaluable subjects for the primary endpoint. The two protocols are identical, and the trials were run simultaneously to enroll subjects concurrently in the United States (US) and Outside United States (OUS). The poolability on the primary endpoint between US and OUS data will be assessed using Fisher's exact test during the data analysis. Data for both trials will be combined and presented as a pooled analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02625324
Study type	Interventional
Source	Medtronic Cardiovascular
Contact
Status	Completed
Phase	N/A
Start date	April 2016
Completion date	March 2, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02777593` - Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2	N/A
Completed	`NCT02876263` - Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta	N/A
Terminated	`NCT02538822` - Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging	N/A
Completed	`NCT04930172` - TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry
Completed	`NCT03207568` - RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)	N/A
Recruiting	`NCT03010514` - A Registry Study on Genetics and Biomarkers of Thoracic Aortic Aneurysm/Dissection	N/A
Completed	`NCT02266342` - GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
Completed	`NCT00757003` - To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease	Phase 3
Recruiting	`NCT03574311` - Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery	Phase 4
Suspended	`NCT03410420` - Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride	Phase 1
Recruiting	`NCT05703893` - Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)
Enrolling by invitation	`NCT05800743` - Evaluation of the GORE® Ascending Stent Graft	N/A
Completed	`NCT02253082` - Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)	Phase 4
Recruiting	`NCT02323581` - Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts	N/A
Active, not recruiting	`NCT03414866` - Thoraflex Hybrid Post-Market Study
Recruiting	`NCT01985906` - Safety and Efficacy of Multiple Overlapping Uncovered Stents for Pararenal Aortic Aneurysm Repair	N/A
Active, not recruiting	`NCT02818972` - RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers	N/A
Completed	`NCT03479164` - Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms	N/A
Completed	`NCT01775046` - Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)
Recruiting	`NCT04814238` - Minimally Invasive Aortic Root and Aorta surGery rEgistry