MBA Early Feasibility Study

NCT07564375 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: MBA 25-04
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Thoracic Aortic Aneurysm; Penetrating Aortic Ulcers (PAUs); Thoracic Aortic Dissection; Pseudoaneurysm

Keywords

MBA 25-04

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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)

  Through 30 days post-index endovascular procedure, unless otherwise specified.

Secondary Outcomes (2)

• Absence of Select Events

  Initiation of the index procedure through all follow up windows (1-, 6-, 12-, 24-, 36-, 48-, 60-Months), unless indicated.

• Health-Related Quality of Life (via SF-36® Questionnaire)

  1-, 6-, 12-, 24-, 36-, 48-, and 60-Months

Study Arms (1)

MBA device

EXPERIMENTAL

Endovascular repair using the MBA device and, when indicated, the ASG or CTAG devices.

Device: GORE® Multibranch Arch Endoprosthesis; Device: GORE® Ascending Stent Graft

Interventions

GORE® Multibranch Arch Endoprosthesis DEVICE

Primary Investigational Device

Also known as: MBA device

MBA device

GORE® Ascending Stent Graft DEVICE

Secondary Investigational Device

Also known as: ASG device

MBA device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead
• NAMSA: collaborator

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Penetrating Atherosclerotic Ulcer; Dissection, Thoracic Aorta; Aneurysm, False

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Dissection; Dissection, Blood Vessel

Central Study Contacts

Clinical Study Manager

CONTACT

800-437-8181; MBAEarlyFeasibilityStudy@wlgore.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2034
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share