Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts (NCT02323581) | Clinical Trial Compass
RecruitingNot Applicable
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
United States520 participantsStarted 2013-11
Plain-language summary
Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.
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 TAAA in:
. Men with TAAA greater than or equal to 6 cm in diameter
. Women with TAAA greater than or equal to 5 cm in diameter
. Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
. Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
. Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter
. Life expectancy more than 2 years
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.
. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol
Exclusion criteria
. Rupture, with hypotension (systolic bp \< 90).
. Pregnancy or breastfeeding.
. Unwillingness or inability to comply with the follow up schedule.
. Serious systemic or groin infection.
. Uncorrectable coagulopathy.
. Age \< 18 years.
. Mycotic aneurysm.
. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).