At a glance
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Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
In Brief
A clinical study evaluating GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis for Thoracoabdominal Aortic Aneurysm. Active but no longer recruiting, targeting 102 participants across 44 sites in 2 countries.
Detailed Summary
Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)
Study Details
Timeline
Interventions
Endovascular Aortic Stent-Graft