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 range18 Years

SexALL

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

✕. 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.
✕. 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.

What they're measuring

Device Technical Success

Timeframe: Perioperative

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.

Trial details

NCT IDNCT07564375

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-11

Contact for this trial

Clinical Study Manager

800-437-8181 MBAEarlyFeasibilityStudy@wlgore.com

View on ClinicalTrials.gov More Thoracic Aortic Aneurysm trials