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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

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 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

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.

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.

Find a Location

Who is running the clinical trial?

Sanford HealthLead Sponsor
49 Previous Clinical Trials
61,701 Total Patients Enrolled
Patrick Kelly, MD4.621 ReviewsPrincipal Investigator - Sanford Health
Munroe Regional Medical Center
Medical School - New York Institute of Technology, New York College of Osteopathic Medicine, Doctor of Osteopathic Medicine
Florida Medical Center, Residency in Family Practice
5 Previous Clinical Trials
348 Total Patients Enrolled
5Patient Review
Another great visit! They are always so efficient and I appreciate that.

Media Library

Thoracoabdominal Aneurysms Research Study Groups: Primary Study Arm, Expanded Selection Arm
Unitary Manifold (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02294435 — N/A
~24 spots leftby Sep 2025
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