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Stent Graft

Stent-Graft for Aortic Aneurysm (IDE#2 Trial)

N/A

Recruiting

Led By Gustavo S. Oderich, MD FACS

Research Sponsored by Gustavo S. Oderich

Eligibility Criteria Checklist

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

Must have

Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria

Proximal aortic fixation zone: Native aorta or surgical graft; Diameter: 20-42mm; Proximal neck length ≥ 20mm; Ascending aortic length ≥50mm; Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion

Must not have

Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral/iliac access

Leaking or ruptured aneurysm associated with hypotension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of stent-graft to see if it is safe and effective in repairing aortic aneurysm.

Who is the study for?

Adults with specific aortic aneurysms or dissections who are not pregnant, breastfeeding, or have a life expectancy under 2 years. They must be willing to follow the trial schedule and give consent. Exclusions include recent surgeries unrelated to the condition, participation in certain other trials, allergies to device materials, uncorrectable coagulopathy, active infections, certain connective tissue disorders.

What is being tested?

The Zenith t-Branch and customized stent-graft systems are being tested for safety and effectiveness in repairing complex aortic aneurysms. These devices use fenestrations/branches designed for each patient's unique anatomy.

What are the potential side effects?

Potential side effects may include reactions to device materials (stainless steel, nitinol), complications from implantation like bleeding or infection, allergic reactions to contrast material used during surgery if pre-medication is insufficient.

Eligibility Criteria

Inclusion Criteria

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

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I have an aneurysm in both my chest and upper stomach area.

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My aorta fits the required size and position for the procedure.

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My aneurysm has grown at least 0.5 cm in a year.

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My aorta or graft is 20-42mm wide with a neck length of at least 20mm.

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My aortic dissection can be accessed and treated with a stent through my groin.

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My aorta is enlarged, measuring 5.5 cm or more, or twice its normal size.

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I have a large aneurysm in my chest or abdomen and in the arteries to my legs.

Exclusion Criteria

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

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I cannot have surgery for a pathway in my hip area due to access issues.

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I have a leaking or ruptured aneurysm with low blood pressure.

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My blood vessels are not suitable for a specific stent due to blockage or size.

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I cannot or will not give my consent to participate.

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I have a fungal infection in my artery or an active infection throughout my body.

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I am under 18 years old.

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I have a blood clotting disorder that cannot be corrected.

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My veins are too small for the needed medical equipment.

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My aorta is the right size and shape for the procedure, without major calcium deposits or clots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of subjects who experience a Major Adverse Event at 30 days post treatment

Number of subjects who have died at 30 days post treatment

Secondary study objectives

Mean Quality of Life Measure at Various Time Points

Percentage of subjects who achieve treatment success

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: Thoracoabdominal Aortic Aneurysm ArmExperimental Treatment1 Intervention

The TAAA study arm will include patients treated by endovascular aortic repair of thoracoabdominal aortic aneurysms (Extent I to IV) using either an off-the-shelf Zenith t-Branch or patient-specific stent-graft with a combination of fenestrations and/or branches. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.

Group II: Aortic Arch Aneurysm ArmExperimental Treatment1 Intervention

Aortic Arch study arm will include patients with aortic arch aneurysms treated by Patient-specific stent-grafts with one to three inner branches or a scallop. The study will include patients with thoracoabdominal and/or aortic arch aneurysms due to degenerative aneurysms or chronic aortic dissections. The stent-graft design for this study will be individually selected based on anatomy at the discretion of the principal investigator, including an off-the-shelf stent-graft (t-Branch stent-graft) or patient-specific stent-graft with a combination of fenestrations and/or branches.

0 / 16Eligibility criteria met