What side effects are associated with this type of intervention?

Common side effects of treatments for thoracoabdominal aortic aneurysms, particularly those involving endovascular repair with devices like the Thoracic Bifurcation and Visceral Manifold or Unitary Device, include endoleaks, device migration, stent graft infolding or collapse, and aortic rupture. Other complications can involve infection, access site issues such as bleeding or hematoma, and renal complications due to contrast use during the procedure.

What prior FDA approvals exist?

The FDA has approved several endovascular devices for the treatment of thoracoabdominal aortic aneurysms, focusing on stent grafts that provide structural support to the aorta. Notable approvals include the Gore TAG Thoracic Endoprosthesis and the Zenith TX2 TAA Endovascular Graft, which are designed to reinforce the aortic wall and prevent aneurysm rupture. These devices are similar in function to the thoracic bifurcation and visceral manifold or unitary devices being studied, as they aim to provide durable and minimally invasive solutions for complex aortic aneurysms.

What other types of research exist?

Promising novel alternatives for treating thoracoabdominal aortic aneurysms in 2024 include advanced endovascular aneurysm repair (EVAR) techniques, such as fenestrated and branched stent grafts, which allow for customized treatment of complex aneurysms involving branch vessels. Additionally, hybrid procedures combining open surgical and endovascular approaches are gaining traction for their ability to address challenging anatomical variations. Continuous improvements in imaging and navigation technologies also enhance the precision and safety of these interventions.

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Device

New Aortic Repair Device for Aortic Aneurysm

N/A

Waitlist Available

Led By Patrick Kelly, MD

Research Sponsored by Sanford Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Saccular aneurysm deemed at significant risk for rupture

Proximal landing zone for the unitary manifold stent graft: Nonaneurysmal aortic segment including previously placed graft material (neck) with a minimum seal zone length of 3 cm, Diameter in the range of 19-32 mm, Iliac artery or aortic distal fixation site greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm

Must not have

Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)

Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications related to the implantation procedure such as bleeding or infection, allergic reactions to device materials like nitinol or PTFE, blood vessel damage during insertion of the manifold or stent grafts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My aneurysm is at high risk of bursting.

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

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I am 18 years old or older.

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I have a large aneurysm causing symptoms.

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My aorta near the left subclavian artery is suitable for a stent graft.

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My aneurysm grew by at least 0.5 cm in the last 6 months.

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My aneurysm is at least 5.5 cm or twice the size of the normal artery near it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My body size may prevent clear x-ray images or is too large for the equipment.

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I have worsening chest pain, including new pain at rest or at night.

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I have a tear in the part of my aorta that needs treatment.

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My anatomy allows for at least one open hypogastric artery.

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My anatomy prevents proper blood flow in my left subclavian artery.

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I have had a ruptured aneurysm.

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I have had a stent placed in one of my body's main blood vessels.

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I have a contained rupture.

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I had surgery to repair an aneurysm and may need a new procedure that goes beyond the previous repair area.

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I have a blood clotting disorder that cannot be corrected.

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I am allergic or react badly to blood thinners or contrast dyes that can't be managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Freedom from major adverse events (MAEs) at 30 days

Secondary study objectives

Treatment success and technical success at 1 year

Treatment success at various timepoints

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for thoracoabdominal aortic aneurysms (TAAAs) include open surgical repair, endovascular repair, and hybrid approaches. Open surgical repair involves replacing the aneurysmal section of the aorta with a synthetic graft, providing direct structural support. Endovascular repair uses stent-grafts inserted via catheters to reinforce the weakened aortic wall from within, minimizing the need for extensive surgery. Hybrid approaches combine elements of both techniques, often involving debranching procedures to maintain blood flow to vital organs while placing stent-grafts. These treatments are crucial for TAAA patients as they aim to prevent aneurysm rupture, which can be life-threatening, by providing necessary structural support to the compromised aorta.

Thoracoabdominal aortic aneurysm repair: open, endovascular, or hybrid?Fenestrated grafts or debranching procedures for complex abdominal aortic aneurysms.