CompletedNot Applicable

Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms

United States31 participantsStarted 2014-01

Plain-language summary

The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Presence of DTA aneurysm deemed to warrant surgical repair which requires proximal graft placement in Zone 2:
. Fusiform (≥ 55 mm), or
. Fusiform (\>2 times native aortic diameter), or
. Saccular (no diameter criteria)
. Age ≥18 years at time of informed consent signature
. Subject is capable of complying with protocol requirements, including follow-up
. Informed Consent Form (ICF) is signed by Subject or legal representative
. Must have appropriate proximal aortic landing zone, defined as:

Exclusion criteria

. Aortic inner diameters between 16-48 mm
. Landing zone, which must include the LSA ostium, cannot be aneurysmal, heavily calcified, or heavily thrombosed,
. Acceptable proximal landing zone outer curvature length for the required device

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Successful Study Device Access

Timeframe: During treatment procedure (day 0)

Number of Participants With Successful Study Device Deployment

Timeframe: During treatment procedure (day 0)

Number of Participants With Primary Procedural Side Branch Patency as Assessed by Angiography

Timeframe: At conclusion of the treatment procedure (day 0)

Trial details

NCT IDNCT02021812

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08

Results submitted2017-07-07

View on ClinicalTrials.gov More Aortic Aneurysm, Thoracic trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Presence of DTA aneurysm deemed to warrant surgical repair which requires proximal graft placement in Zone 2:
. Fusiform (≥ 55 mm), or
. Fusiform (\>2 times native aortic diameter), or
. Saccular (no diameter criteria)
. Age ≥18 years at time of informed consent signature
. Subject is capable of complying with protocol requirements, including follow-up
. Informed Consent Form (ICF) is signed by Subject or legal representative
. Must have appropriate proximal aortic landing zone, defined as:

Exclusion criteria

. Aortic inner diameters between 16-48 mm
. Landing zone, which must include the LSA ostium, cannot be aneurysmal, heavily calcified, or heavily thrombosed,
. Acceptable proximal landing zone outer curvature length for the required device

What they're measuring

Number of Participants With Successful Study Device Access

Timeframe: During treatment procedure (day 0)

Number of Participants With Successful Study Device Deployment

Timeframe: During treatment procedure (day 0)

Number of Participants With Primary Procedural Side Branch Patency as Assessed by Angiography

Timeframe: At conclusion of the treatment procedure (day 0)