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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P230023 / PAS002 |
| Date Original Protocol Accepted |
03/22/2024
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| Date Current Protocol Accepted |
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| Study Name |
GORE TAMBE Post-Approval Study
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| Device Name |
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is prospective, single-arm, multicenter post-market study designed to collect clinical outcomes data from subjects who have been treated with the TAMBE Aortic Component (AC).
The objective of the study is to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program
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| Study Population |
Patients who receive the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) Aortic Component (AC) used in endovascular repair.
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| Sample Size |
Number of subjects: 300
Assumptions for sample size estimation: NA
Number of sites: 60; a minimum of 10 new sites (i.e., sites without prior TAMBE implant experience) will contribute to the data collection.
Sites location: United States
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| Key Study Endpoints |
Two co-primary endpoints are proposed:
5.4.1 Technical Success
Defined utilizing criteria outlined in the SVS reporting standards, in which all of the following qualifying criteria are met (in the absence of surgical conversion or mortality, type I or type III endoleaks, branch occlusion, or graft limb obstruction):
Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits at index procedure.
Successful delivery and deployment of the aortic stent graft and all modular stent graft components at index procedure.
Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels at final completion angiography.
Absence of type I or type III endoleaks at final completion angiography.
Patency of all aortic modular stent graft components and intended side branch components at final completion angiography.
5.4.2 Clinical Success
Defined utilizing criteria outlined in the SVS reporting standards, in which all of the following qualifying criteria are met from the initiation of the TAMBE Device implant procedure through 12 months post-index procedure:
Technical success
Absence of death from the initial procedure, secondary intervention, or aorta-related cause.
Absence of persistent type I or type III endoleak
Absence of lesion enlargement > 5 mm
Absence of device migration > 10 mm
Absence of failure due to device integrity issues
Absence of lesion rupture
Absence of conversion to open surgical repair
Absence of permanent paraplegia
Absence of disabling stroke
Absence of "loss of function" or "end-stage renal disease" stage according to the RIFLE Classification following the index procedure
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