New Aortic Repair Device for Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byPatrick W Kelly, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sanford Health

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing special devices to fix a damaged artery in the chest and abdomen. It focuses on patients with a specific type of artery damage. The devices work by providing internal support to the weakened artery, offering a more individualized treatment option.

Eligibility Criteria

Adults with thoracoabdominal aortic aneurysms that are large, growing, or at risk of rupture can join this trial. They must have specific vessel sizes and access points for the devices used in the study. Those with recent major procedures, infections, certain connective tissue disorders, allergies to device materials, kidney issues (high creatinine levels), or poor overall health cannot participate.

Inclusion Criteria

You are expected to live for more than 1 year.

My aorta fits the size and condition requirements for a specific stent graft.

I am 18 years old or older.

+7 more

Exclusion Criteria

Urgent or emergent presentation

Patient is pregnant or breastfeeding

I have major issues with two of my body systems like heart, lungs, kidneys, liver, or muscles.

+21 more

Participant Groups

The study is testing two different devices: Visceral Manifold and Thoracic Bifurcation versus Unitary Manifold for repairing aortic aneurysms. It aims to evaluate their safety and effectiveness over time by monitoring patients who receive these treatments.

2Treatment groups

Experimental Treatment

Group I: Primary Study ArmExperimental Treatment2 Interventions

The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcation and the Visceral Manifold and the Unitary Manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.

Group II: Expanded Selection ArmExperimental Treatment2 Interventions

The expanded selection arm is for subjects not eligible for open repair or other endovascular options due to comorbidities or anatomical limitations and do not meet inclusion in the primary study arm. The Thoracic Bifurcation and the Visceral Manifold as well as the Unitary Manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.