Endovascular Repair for Thoracoabdominal Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Matthew Eagleton

No Placebo Group

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.

Treatment Details

Interventions

• Valiant Thoracoabdominal Stent Graft System (Stent Graft)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Massachusetts General Hospital Boston, MA

Who Is Running the Clinical Trial?

Matthew Eagleton Lead Sponsor

Medtronic Industry Sponsor

NAMSA Collaborator

Sanford Health Collaborator

References