MBA Early Feasibility Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
W.L.Gore & Associates
Study ID
NCT07564375
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GORE® Multibranch Arch Endoprosthesis — DEVICE
    Primary Investigational Device
  • GORE® Ascending Stent Graft — DEVICE
    Secondary Investigational Device

Study Details

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 Dates

First listed
May 4, 2026
Start date
Sep 2, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2033

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

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

Primary Outcome Measure

Device Technical Success [ Time Frame: Perioperative ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033
Sukgu Han, MD
Baylor Research InstitutePlanoTexas75093
Mazin Foteh, MD

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By research site
University of Southern California· Los Angeles, CABaylor Research Institute· Plano, TX

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