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MBA Early Feasibility Study

NCT07564375 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-06-01

No results posted yet for this study

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

Interventions

DEVICE

GORE® Multibranch Arch Endoprosthesis

Primary Investigational Device

DEVICE

GORE® Ascending Stent Graft

Secondary Investigational Device

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • W.L.Gore & Associates

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-11-30
Completion
2034-11-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07564375 on ClinicalTrials.gov