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.
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 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.
De novo Type A dissection
Requires immediate treatment.
Arch vessels with dissection extending into the intended landing zones.
Anticipated need for coronary or aortic valve intervention within one year post-treatment.
W.L.Gore & Associates
Lead sponsor
NAMSA
Collaborator