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.
Single group
GORE® Multibranch Arch Endoprosthesis
DevicePrimary Investigational Device
GORE® Ascending Stent Graft
DeviceSecondary Investigational Device
Device Technical Success
* Successful access and delivery to the intended implantation site, and retrieval of the device delivery system, * Patency of the graft, and * The absence of unanticipated additional procedures related to the device, procedure, or withdrawal of the delivery system.
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
An absence of the following: * Lesion-related mortality * Disabling stroke * Permanent paraplegia * New onset renal failure resulting in permanent dialysis * Aortic rupture * Conversion * Loss of aortic component / branch patency (through the end of the 1-Month window)
Absence of Select Events
An absence of the following events: All-cause mortality, Lesion-related mortality, Life-threatening bleed (index endovascular procedure only), Myocardial infarction (MI) (through the end of the 1-Month window), Aortic rupture, Stroke, Disabling stroke, Transient Ischemic Attack (TIA), Loss of aortic component or branch patency, Endoleaks, New dissection, Unanticipated Reintervention including Conversion
Health-Related Quality of Life (via SF-36® Questionnaire)
Change in health-related quality of life (HRQoL) from baseline (pre-treatment) will be assessed using the SF-36® questionnaire.
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W.L.Gore & Associates
Lead sponsor
NAMSA
Collaborator
