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Thoracic Aortic AneurysmNCT07564375

MBA Early Feasibility Study

A study testing GORE® Multibranch Arch Endoprosthesis and GORE® Ascending Stent Graft in people with Thoracic Aortic Aneurysm and Penetrating Aortic Ulcers (PAUs), run by W.L.Gore & Associates at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GORE® Multibranch Arch Endoprosthesis and GORE® Ascending Stent Graft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesUnited States
Study dates
2 Sep 2026to Aug 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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).
  • 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.
  • Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (> 30 days post-treatment).
  • Proximal extension of prior endovascular repair (> 30 days post-treatment and > 90 days post-dissection) of a Type B dissection requiring treatment.
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  • 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:
  • Landing zone is native aorta, surgical graft, or previously implanted GORE thoracic stent graft.
  • 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.
  • 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).
  • 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.
  • Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed.
  • 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.
  • Target branch vessel landing zone must be in native aorta that cannot be heavily calcified, or heavily thrombosed.
  • All three arch target vessels must have appropriate anatomy for cannulation (including through-wire access) and treatment with MBA branch components.
  • 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.
  • Landing zone in native aorta, surgical graft, or previously implanted GORE thoracic stent graft.
  • Age ≥ 18 years at time of informed consent signature.
  • Informed Consent Form (ICF) signed by the subject or legally authorized representative (LAR), according to local regulation.
  • Agrees to comply with protocol requirements, including imaging and five year (60 month) follow-up.
  • Considered high-risk for open surgical repair by meeting one or more of the following criteria:
  • ≥ 75 years of age
  • Previous median sternotomy
  • Documented identification of other subject-specific risk factors (e.g., medical history, active medical diagnosis) by a study investigator and an experienced open ascending and / or aortic arch surgeon (e.g., cardiothoracic surgeon).
  • Considered high-risk for surgical debranching by meeting one or more of the following criteria:
  • Prior neck surgery or radiation
  • Neck anatomy / body habitus impeding carotid access or safe bypass tunneling
  • Dysphagia
  • Elevated risk for post-operative infection (e.g., malnutrition, uncontrolled diabetes (hemoglobin A1c > 9%), current treatment with immunosuppressant therapy or chemotherapy)
  • Reduced pulmonary function (e.g., severe chronic obstructive pulmonary disease (COPD), current or anticipated tracheostomy)
  • Clinical Frailty Scale score 6-7
  • Documented identification of other subject-specific risk factors which would pose high risk for surgical debranching (e.g., medical history, active medical diagnosis) by a study investigator

Who cannot join

  • 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.
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  • 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.
  • Known sensitivities or allergies to the device materials.
  • Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
  • Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta.
  • Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin or a history of a hypercoagulability disorder and / or state.
  • Severe Congestive Heart Failure (CHF) (New York Heart Association (NYHA) functional class IV).
  • Acute Coronary Syndrome (ACS) including unstable angina.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Study Manager contact

800-437-8181

MBAEarlyFeasibilityStudy@wlgore.com

United States3 sites, 3 recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Eric Roselli, MD

    Recruiting

  • University of Southern California

    Los Angeles, California, 90033

    Sukgu Han, MD

    Recruiting

  • Baylor Research Institute

    Plano, Texas, 75093

    Mazin Foteh, MD

    Recruiting

Other trials in United States

About this study

Official title: Early Feasibility Study of the GORE® Multibranch Arch Endoprosthesis (MBA Device)

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.

Read the detailed description

This study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to collect outcomes for subjects treated with the MBA device through five years following the index endovascular procedure. Due to the early feasibility phase of the study, this study utilizes a non-randomized single-arm design with descriptive outcomes, with the primary objective of providing initial safety data.

A maximum of 14 clinical investigative sites in the U.S. and Europe will participate in this study, with up to 12 sites located in the U.S., and up to 2 sites located in Europe.

Enrollment will be conducted in two sequential phases:

  • Phase 1: Initial Enrollment
  • The first five implanted subjects will be Dissection pathology (including residual Type A dissections, uncomplicated and high-risk chronic Type B dissections).
  • Phase 2: Expanded Enrollment o Following completion of the Initial Enrollment phase, eligibility will broaden to include all planned pathologies: Dissection, Aneurysm, and Other Isolated Lesion (i.e., pseudoaneurysm, PAU without IMH).

Enrollment will continue until a minimum of five Dissection subjects, and a minimum of five Aneurysm / Other Isolated Lesion subjects have been implanted, with a total of 10-20 implanted subjects across all eligible pathologies. A maximum of 15 subjects will be implanted at U.S. sites and a maximum of five will be implanted at European sites

Being tested
GORE® Multibranch Arch Endoprosthesis, GORE® Ascending Stent Graft
Keywords
MBA 25-04
Medical subject headings
Aortic Aneurysm, Thoracic, Penetrating Atherosclerotic Ulcer, Dissection, Thoracic Aorta, Aneurysm, False

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GORE® Multibranch Arch EndoprosthesisDevice

    Also called MBA device

    Primary Investigational Device

  • GORE® Ascending Stent GraftDevice

    Also called ASG device

    Secondary Investigational Device

Study groups in NCT07564375
Study groupRoleWhat they receive
MBA deviceExperimentalEndovascular repair using the MBA device and, when indicated, the ASG or CTAG devices.
Receives: Device: GORE® Multibranch Arch Endoprosthesis; Device: GORE® Ascending Stent Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Perioperative

  2. 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)

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

Secondary outcomes (2)

  1. 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

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start2 Sep 2026
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07564375
Sponsor's protocol ID
MBA 25-04
Status last verified
Sep 2026
First submitted
15 Apr 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GORE® Multibranch Arch Endoprosthesis and GORE® Ascending Stent Graft in people with Thoracic Aortic Aneurysm and Penetrating Aortic Ulcers (PAUs), run by W.L.Gore & Associates at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Study Manager (800-437-8181, MBAEarlyFeasibilityStudy@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Technical Success (time frame: Perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07564375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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