Retrospective Real-World Data Collection of the Conformable GORE® TAG® Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for Treatment of Aortic Aneurysms and Dissections

NCT07742592 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: TAG 25-09
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure

Conditions

Dissection of Aorta; Aneurysm Aortic; Frozen Elephant Trunk

Keywords

frozen elephant trunk; aortic aneurysm; Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• MAE freedom within one year (365 days) post-implant

  The primary endpoint will be measured as freedom from the composite of the following major adverse events (MAE) occurring within one year (365 days) post-implant: * Permanent Stroke * Permanent Paraplegia/ Paraparesis * Mortality * Reoperation

  From date of index procedure through 365 days post implant

Secondary Outcomes (1)

• Freedom from imaging outcomes within the 12-Month analysis window

  From the date of the index procedure through end of 12 months analysis window unless otherwise specified

Study Arms (2)

Chronic/Subacute Dissections and Aneurysms

Chronic/Subacute Dissections and Aneurysms

Device: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure

Acute/Hyperacute Dissections

Acute/Hyperacute Dissections

Device: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure

Interventions

Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure DEVICE

Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure

Acute/Hyperacute Dissections; Chronic/Subacute Dissections and Aneurysms

Eligibility Criteria

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

Study Population

The patient pool from which sites will screen for enrollment is comprised of patients with history of thoracic aortic disease that required surgical repair using a FET procedure. For qualifying patients with dissections, they will be enrolled into either of the following cohorts: * Hyperacute: onset of symptoms must be documented to be \<24 hours prior to the date of the procedure. * Acute: onset of symptoms must be documented to be 1-14 days prior to the date of the procedure. * Subacute: onset of symptoms must be documented to be 15-90 days prior to the date of the procedure. * Chronic: onset of symptoms must be documented to be more than 90 days prior to the date of the procedure. Those patients who meet all inclusion and no exclusion criteria, will be eligible for enrollment in this retrospective study.

You may qualify if:

• Treated for aneurysm or dissection using antegrade deployed Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device at least 12 months prior to date of enrollment.
• Age ≥ 18 years at the time of the index procedure.
• Proximal extent of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device is sutured to the aorta and/or distal aspect of the surgical graft.
• Informed Consent Form (ICF) is signed by the subject or a legally authorized representative, or a waiver of consent is granted by the IRB of record and appropriately documented by the enrolling site.

You may not qualify if:

• Any modification performed on the CTAG Device, excluding suturing.
• Procedure performed in the setting of infection requiring treatment with parenteral anti-infective medication.
• Pregnant at the time of the index procedure.
• Aneurysm or Subacute / Chronic Dissection cases (onset of symptoms ≥15 days prior to the date of the procedure) with documented aortic rupture at the time of the index procedure.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

MeSH Terms

Conditions

Aortic Dissection; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Central Study Contacts

Harrison Lead Clinical Study Manager

CONTACT

12068225653; hkelner@wlgore.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share