GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

NCT06578741 | Enrolling By Invitation FDA Device

• 1 other identifier: AAA 24-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims 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.

Conditions

Abdominal Aortic Aneurysm; Pararenal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Co-Primary Endpoint #1: Technical Success

  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.

  Time of index procedure

• Co-Primary Endpoint #2: Clinical Success

  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

  Index procedure through 12 months

Secondary Outcomes (15)

• Target Vessel Technical Success

  30 days, 6 months, annually through 10 years

• Secondary Clinical Success

  30 days, 6 months, annually through 10 years

• Assisted Primary Clinical Success

  30 days, 6 months, annually through 10 years

• Thirty-Day Mortality

  30 days

• Lesion-Related Mortality

  30 days, 6 months, annually through 10 years

Study Arms (1)

Single Arm

OTHER

Treatment with GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)

Interventions

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) DEVICE

Treatment with the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in patients with Pararenal Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is / has:
• Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels.
• Age ≥18 years at the time of informed consent signature.
• An Informed Consent Form signed by subject or legal representative.

You may not qualify if:

• The subject is / has:
• Any contraindications for the TAMBE Device according to the IFU.
• Planned parallel grafting with the TAMBE Aortic Component.
• Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

Stanford Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2036
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)