A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular… (NCT07754240) | Clinical Trial Compass
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A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm
Bulgaria45 participantsStarted 2026-09-30
Plain-language summary
The objective of this clinical investigational study is to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (i.e., IE stent grafts with distal diameters of 24, 26, and 28 mm) for endovascular treatment of abdominal aortic aneurysm in patients with infrarenal abdominal aortic aneurysm who are suitable for endovascular intervention.
The primary safety endpoint is the incidence of major adverse events within 30 days after the procedure. The primary efficacy endpoint is the 12-month treatment success rate.
Who can participate
Age range
18 Years – 80 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
. 18 years ≤ age ≤80years, no gender limitation.
. Patients diagnosed with infrarenal abdominal aortic aneurysm and should meet at least one of the following conditions:
. The maximum diameter of abdominal aortic aneurysm is 55 mm or more in male patients or 50 mm or more in female patients;
. The maximum diameter of abdominal aortic aneurysm has increased by more than 5 mm in the last 6 months or 10 mm in the last 1 year;
. Abdominal aortic aneurysm oppresses important organs and viscera and causes symptoms (such as abdominal pain, lower back pain, etc.).
. Anatomical criteria:
. Patients who are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent form, and are willing to complete the follow-up visits as per the protocol.
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
The incidence of Major adverse events (MAEs) within 30 days after operation.
Timeframe: within 30-day post operation
2
12-month treatment success rate
Timeframe: intraoperative and 12-month post operation
. Patients with ruptured or leaking abdominal aortic aneurysm;
. Patients with infectious abdominal aortic aneurysm;
. Patients with abdominal aortic dissection;
. Patients with traumatic aortic disease;
. Patients with severe stenosis, calcification or mural thrombus in the stent anchoring zone likely to cause difficult covered stent apposition or the impact on stent patency;
. Patients with mesenteric blood flow mainly supplied by the inferior mesenteric artery;
. Patients with accessory renal artery original from abdominal artery;
. Patients who have undergone abdominal aortic surgery or endovascular intervention;