NCT06578741

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

Active, Not Recruiting
NAAges 18+InterventionalTreatment
W.L.Gore & Associates
~310 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Co-Primary Endpoint #1: Technical Success
Measured over Time of index procedure
+1 more outcome measured
Abdominal Aortic Aneurysm
Pararenal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
1 sites across 1 states
California1

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Co-Primary Endpoint #1: Technical SuccessTime of index procedure

    All of the qualifying criteria are met (in the absence of surgical conversion or mortality, type I or type III endoleak, 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.

  • Co-Primary Endpoint #2: Clinical SuccessIndex procedure through 12 months

    All of the following qualifying criteria are met from the initiation of the index 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 (defined as Grade 2 or 3 in Table 8) * Absence of lesion rupture * Absence of conversion to open surgical repair * Absence of permanent paraplegia (see definition below) * Absence of disabling stroke (see definition below) * Absence of "loss of function" or "end-stage renal disease" stage according to the RIFLE Classification following the index procedure