Endovascular Repair for Thoracoabdominal Aortic Aneurysm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Matthew Eagleton

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

15 Participants Needed

Trial Summary

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.

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Primary Study Arm Experimental Treatment 1 Intervention

The Valiant Thoracoabdominal Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcate and the Visceral Manifold. These devices work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.

Group II: Expanded Use Arm Experimental Treatment 1 Intervention

The Valiant Thoracoabdominal Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcate and the Visceral Manifold. These devices work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. The expanded use arm provides broaden inclusion criteria to include select patients excluded from the primary study arm.

Who Is Running the Clinical Trial?

Matthew Eagleton

Lead Sponsor

Trials

2

Recruited

190+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

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+