TerminatedNot Applicable

Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)

Stopped: Study device discontinued \& insufficient sample size for statistical results.

United States349 participantsStarted 2009-04

Plain-language summary

The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval.

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: appropriate anatomy for elective repair of the descending thoracic aortic aneurysm * iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and or accessories * non-aneurysmal aortic diameter in the range of 18-42mm; and * non-aneurysmal aortic proximal and distal neck lengths equal to or greater than 20mm * subject has a Descending Fusiform Thoracic Aneurysm = to or greater than 5cm in diameter OR is = to or greater than 2 times the diameter of the non-aneurysmal thoracic aorta and/or saccular aneurysms/penetrating ulcers * Signed patient informed consent Exclusion Criteria: * Less than 18 yrs old * pregnant * unable to comply w/follow-up * participating in other drug or device trials; * Subject has a co-morbidity causing expected survival to be less than 1 year

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

Freedom From Aneurysm-related Mortality at 5 Years

Timeframe: 5 years

Trial details

NCT IDNCT00805948

SponsorMedtronic Cardiovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08

Results submitted2017-09-19

View on ClinicalTrials.gov More Thoracic Aortic Aneurysms 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.