MBA Early Feasibility Study (NCT07564375) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
MBA Early Feasibility Study
20 participantsStarted 2026-09
Plain-language summary
The MBA 25-04 study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to assess the initial safety of the MBA device through five years following the index endovascular procedure.
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
. Thoracic pathologies with involvement of the arch branch vessels, that are compatible with the treatment requirements of the MBA device, and meeting any of the following criteria:
. Anatomic compatibility with MBA device and other devices required for proximal or distal extensions based on Gore's review.
. Adequate vascular access via transfemoral or retroperitoneal approach.
. Appropriate vascular access to allow for through-wire access to the brachiocephalic artery, LCCA, and LSA.
. Proximal Aortic Landing Zone:
. Proximal segment length (length from distal edge of brachiocephalic artery to distal edge of the most distal coronary artery) must be ≥ 2 cm longer than the "AC Proximal End to BCA Portal Length" for the selected Aortic Component or ≥ 3 cm if the landing zone is \> 42 mm.
. For patients with patent bypass graft from the ascending aorta, proximal extent of landing zone must be ≥ 1 cm distal to the bypass graft.
. For patients with prior replacement of the ascending aorta and / or aortic arch by surgical graft, there must be ≥ 2 cm overlap of MBA device and previously implanted graft.
Exclusion criteria
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
Device Technical Success
Timeframe: Perioperative
2
Absence of: Lesion-related mortality, Disabling stroke, Permanent paraplegia, New onset renal failure resulting in permanent dialysis, Aortic rupture, Conversion, Loss of aortic component / branch patency
Timeframe: Through 30 days post-index endovascular procedure, unless otherwise specified.
. Arch vessels with dissection extending into the intended landing zones.
. Anticipated need for coronary or aortic valve intervention within one year post-treatment.
. Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment.
. Complex percutaneous coronary intervention (PCI) within 30 days prior to treatment.
. Open chest surgical repair within 30 days prior to treatment.
. Any open or interventional repair of either carotid artery within 30 days prior to treatment.