Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA (NCT02989948) | Clinical Trial Compass
RecruitingNot Applicable
Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA
United States80 participantsStarted 2020-04-22
Plain-language summary
The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.
Who can participate
Age range
50 Years – 95 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
. Must be a man or woman 50 years of age or older by the date of informed consent.
. Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
. Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta).
. Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.
. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.
. Must be able to provide informed consent.
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
1
30 day survival
Timeframe: 30 Days
2
Major Adverse Events (MAE) at 30 days following surgery
. Must be able to comply with the five year study assessment schedule of events.
. Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years.
Exclusion criteria
. Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.
. Ruptured or acutely symptomatic aortic aneurysm.
. Known connective tissue disorder.
. Imaging demonstrating any of the following:
. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.
. History of anaphylaxis to contrast, with inability to prophylax appropriately.