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Can a stent improve outcomes in High-Risk aortic surgery? a new registry investigates

NCT ID NCT07742592

Knowledge-focused Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study looks back at medical records of about 350 people who had a specific stent graft placed during a complex aortic surgery called a frozen elephant trunk procedure, used to treat aortic aneurysms or dissections. The goal is to see how often major complications like stroke, paralysis, death, or repeat surgery occur within a year. By gathering real-world data, researchers hope to better understand the safety and performance of this device in everyday practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Conformable GORE TAG Thoracic Endoprosthesis (a covered stent graft used during frozen elephant trunk surgery)
What this could lead to
If outcomes are favorable, this could support the safe and effective use of this stent in complex aortic repairs, potentially improving surgical guidance.
What could go wrong
This is a retrospective review, not a controlled trial, so results may be limited by missing data or patient differences. Risks include stroke, paralysis, or need for reoperation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Treated for aneurysm or dissection using antegrade deployed Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device at least 12 months prior to date of enrollment. 2. Age ≥ 18 years at the time of the index procedure. 3. Proximal extent of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device is sutured to the aorta and/or distal aspect of the surgical graft. 4. 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. Exclusion Criteria: 1. Any modification performed on the CTAG Device, excluding suturing. 2. Procedure performed in the setting of infection requiring treatment with parenteral anti-infective medication. 3. Pregnant at the time of the index procedure. 4. 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.

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Conditions

The condition(s) this trial relates to.

aortic aneurysm Aortic Dissection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aneurysm aortic Dissection of aorta Frozen elephant trunk

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.