15 Participants Needed

Endovascular Repair for Thoracoabdominal Aortic Aneurysm

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 primary objective of this study is to assess the use of the thoracic bifurcation and the visceral manifold devices in the repair thoracoabdominal aortic aneurysms in patients with appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.

Are You a Good Fit for This Trial?

This trial is for adults with thoracoabdominal aortic aneurysms that have grown or are symptomatic. Candidates should have specific measurements in their arteries to fit the stent graft and must not be good candidates for open surgery or other treatments. They need at least a year's life expectancy, compatible vessel morphology, and willingness to follow up.

Inclusion Criteria

I have an aneurysm larger than 5.5 cm or twice the size of the normal artery near it.
My artery or graft site for fixation is the right size and length.
I qualify for the study but have a small vessel diameter of less than 5mm.
See 7 more

Exclusion Criteria

I have a contained rupture.
I have a blood clot or severe hardening in the upper part of my aorta.
The blood vessels in the area where the treatment will be done are too small.
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular stenting using the Valiant Thoracoabdominal Stent Graft System

4 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including freedom from major adverse events and treatment success

5 years
Regular follow-up visits at specified intervals

What Are the Treatments Tested in This Trial?

Interventions

  • Valiant Thoracoabdominal Stent Graft System
Trial Overview The Valiant Thoracoabdominal Stent Graft System is being tested for safety and effectiveness in repairing thoracoabdominal aortic aneurysms. The study will evaluate how well it works immediately after placement and over time during follow-up checks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Primary Study ArmExperimental Treatment1 Intervention
Group II: Expanded Use ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Matthew Eagleton

Lead Sponsor

Trials
2
Recruited
190+

Medtronic

Industry Sponsor

Trials
627
Recruited
767,000+
Geoff Martha profile image

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz profile image

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

NAMSA

Collaborator

Trials
55
Recruited
21,500+

Sanford Health

Collaborator

Trials
53
Recruited
2,067,000+
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