20 Participants NeededMy employer runs this trial

GORE Devices for Thoracic Aortic Aneurysm

Recruiting at 1 trial location
CS
Overseen ByClinical Study Manager
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: W.L.Gore & Associates
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with certain aortic conditions, like large or growing aneurysms, pseudoaneurysms after surgery, specific ulcers, or chronic aortic dissections. Participants must have blood vessels that fit the device and allow access for the procedure.

Inclusion Criteria

1. Adequate vascular access via transfemoral or retroperitoneal approach.
2. Appropriate vascular access to allow for through-wire access to the brachiocephalic artery, LCCA, and LSA.
I have a remaining aortic dissection after surgery for Type A dissection that needs treatment.
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What Are the Treatments Tested in This Trial?

Interventions

  • GORE® Ascending Stent Graft
  • GORE® Multibranch Arch Endoprosthesis

Trial Overview

The study is testing the safety of two new stent graft devices (GORE Multibranch Arch Endoprosthesis and GORE Ascending Stent Graft) used to repair damaged sections of the thoracic aorta through minimally invasive surgery. All participants receive these devices.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MBA deviceExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

W.L.Gore & Associates

Lead Sponsor

Trials
103
Recruited
32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School

NAMSA

Collaborator

Trials
55
Recruited
21,500+