Registry in Patients With Thoracoabdominal Aneurysms (NCT03295682) | Clinical Trial Compass
CompletedNot Applicable
Registry in Patients With Thoracoabdominal Aneurysms
Germany47 participantsStarted 2017-09-11
Plain-language summary
In this study patients will be observed, who receive a multi-branch stent graft tailored to the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V.
The objective of this study is to evaluate clinical and technical success as well as safety and feasibility of the multi-branch stent graft Systems used in endovascular treatment of thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices. Primary endpoint of this study is the rate of patients with stable or decreasing aneurysm size at 12 months follow-up.
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:
* Age ≥ 18 years
* Patients must have a thoracoabdominal aneurysm type Crawford type I, II, III, IV, or V
* Patients must have a suitable proximal landing area
* Patients must have a suitable distal landing area in the abdominal aorta or the iliac arteries
* Patients must have suitable access vessels
* Patients must be available for the appropriate follow-up times for the duration of the study
* Patients have signed the informed consent before intervention
Exclusion Criteria:
* Patients with infectious aneurysm
* Patients with inflammatory aneurysm
* Patients with ruptured or symptomatic aneurysm
* Patients with traumatic aneurysm
* Patients with aortic dissection
* Patients who have a congenital degenerative collagen disease or connective tissue disorder
* Patients with thrombocytopenia
* Patients with an eGFR \< 45ml/min/1.73m2 before the intervention
* Patients with untreated hyperthyroidism
* Patients with malignancy needing chemotherapy or radiation
* Patients that will be treated or are treated with iliac branch devices
* Patients pre-treated with Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard Medical) stent grafts
* Patients who are enrolled in another clinical study
* Patients with life expectancy of less than 36 months
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
Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)