MBA Early Feasibility Study

Starting soon · Not applicable

Conditions studied: Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs), Thoracic Aortic Dissection, Pseudoaneurysm

In brief

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.

Key facts

Study ID

NCT07564375

Run by

W.L.Gore & Associates

People needed

20

Starts

2026-09-01

Expected to finish

2034-11-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is / has:
• 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:
• a) Aneurysm and Isolated Lesions: i. Fusiform aneurysm (≥ 55 mm or documented growth rate > 0.5 cm/year). ii. Saccular aneurysm (no diameter criteria). iii. Pseudoaneurysms (> 30 days post-surgery, no diameter criteria). iv. Penetrating Aortic Ulcers (PAUs) without intramural hematoma (IMH) (no diameter criteria).
• b) Aortic dissection: i. Uncomplicated and high-risk chronic de novo (> 90 days) Type B aortic dissection with primary entry tear in the arch or descending thoracic aorta.
• ii. Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (> 30 days post-treatment).
• iii. Proximal extension of prior endovascular repair (> 30 days post-treatment and > 90 days post-dissection) of a Type B dissection requiring treatment.
• iv. Pseudoaneurysms, following open surgical repair of a Type A dissection (> 30 days post-surgery, no diameter 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:
• i. Landing zone is native aorta, surgical graft, or previously implanted GORE thoracic stent graft.
• ii. Landing zone diameter between 27 mm - 48 mm. iii. Acceptable ascending aorta outer curvature length for the required MBA device.
• 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.
• iv. Lesion location is ≥ 2 cm distal to the most distal coronary artery ostium. v. For patients with an existing transcatheter aortic valve replacement (TAVR) there must be a sufficient proximal landing zone to avoid interference with the required MBA device (including any proximal extensions with the ASG device).
• vi. Proximal landing zone must be ≥ 2 cm in the ascending aorta.
• 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.
• For patients with a de novo aortic dissection, the primary entry tear must be located ≥ 2 cm distal to the proximal extent of the MBA device (including any proximal extensions) and the proximal edge of the stent graft must land in non-dissected aorta.
• vii. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed.
• d) Branch Vessel Landing Zone: i. Length of ≥ 2.5 cm proximal to first major branch vessel. ii. Target branch vessel inner diameter of 11-18 mm for the 12 mm portal, and 6-15 mm for the 8 mm portal.
• iii. Target branch vessel landing zone must be in native aorta that cannot be heavily calcified, or heavily thrombosed.
• iv. All three arch target vessels must have appropriate anatomy for cannulation (including through-wire access) and treatment with MBA branch components.
• e) Distal Aortic Landing Zone (aneurysms and isolated lesions only): i. Outer curvature length must be ≥ 2 cm proximal to the celiac artery. ii. Aortic inner diameters between 16-42 mm. iii. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed.
• iv. Landing zone in native aorta, surgical graft, or previously implanted GORE thoracic stent graft.

You may not qualify if…

• The subject is / has:
• 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.
• Presence of Intramural Hematoma (IMH) in landing zones.
• Prosthetic heart valve in the aortic position that precludes safe delivery of any study device.
• Aortic insufficiency (AI) grade 3 or greater.
• Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair.
• Concomitant vascular disease, including disease associated with the great and upper extremity vessels, requiring treatment that is not planned for index endovascular procedure.
• Any stroke or MI within 90 days prior to treatment.
• Presence of protruding and / or irregular thrombus and / or atheroma in the ascending aorta or aortic arch or any other factor that could increase the risk of stroke based on Gore's review.
• Any chronic condition that is not well controlled and that is known to increase stroke risk.
• Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome (EDS)).
• Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor.
• Known medical, social, or psychological issues that the Investigator believes may interfere with treatment or follow-up, such as a history of drug abuse within one year of treatment.
• Pregnant at time of procedure or planning to become pregnant within the first 12-months of participation in the study.
• Active infected aorta, mycotic aneurysm.
• Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).
• Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) < 30 (mL/min/1.73 m2) or currently requiring dialysis.
• Life expectancy <12 months.

Full record on ClinicalTrials.gov

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