What side effects are associated with this type of intervention?

Endovascular repair of Abdominal Aortic Aneurysms (AAA) using Custom-Made Devices (CMDs) and the Zenith Thoracoabdominal Branch Device can lead to several side effects. Common complications include endoleaks, where blood leaks into the aneurysm sac, and device migration or infolding. There is also a risk of spinal cord ischemia, potentially resulting in paraplegia, and renal complications due to the contrast used during the procedure. Other risks include infection, bleeding, and damage to surrounding blood vessels.

What prior FDA approvals exist?

The FDA has approved several endovascular devices for the treatment of Abdominal Aortic Aneurysm (AAA). Notably, the Zenith TX2 and Zenith Thoracoabdominal Branch (t-Branch) devices are used for complex aortic repairs, including thoracoabdominal aneurysms. These devices are similar to the Custom-Made Devices (CMDs) being studied in clinical trials for their ability to accommodate patient-specific anatomy. The Gore TAG device is another FDA-approved endovascular graft used for thoracic aortic aneurysms, offering a less invasive alternative to open surgical repair. These devices have shown promising results in reducing perioperative morbidity and mortality while providing durable aneurysm exclusion.

What other types of research exist?

Promising novel alternatives for the endovascular repair of abdominal aortic aneurysms in 2024 include the use of off-the-shelf fenestrated and branched stent-grafts, which are designed to accommodate a wider range of anatomical variations without the need for custom manufacturing. These devices aim to provide quicker availability and potentially lower costs. Additionally, advancements in polymer-based sealing technology and hybrid devices that combine open and endovascular techniques are also being explored to improve outcomes and reduce complications.

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Device

Endovascular Repair for Aortic Aneurysm

N/A

Waitlist Available

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

Inability or refusal to give informed consent by the patient or a legally authorized representative

Uncorrectable coagulopathy

Must not have

Patients with aortic dissection not meeting the specified criteria

Patients with aortic arch aneurysms or dissections not meeting the specified criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests special medical devices, either custom-made or pre-made, to fix weakened areas in the main blood vessel (aorta) in patients with specific types of aortic aneurysms. These devices support the weakened sections to prevent them from rupturing. The Zenith platform has been used in various studies for treating complex aortic aneurysms.

Who is the study for?

This trial is for adults with specific types of aortic aneurysms (bulges in the wall of the artery) that are at risk of rupture and not suitable for standard treatment. Candidates must have anatomy compatible with custom-made or off-the-shelf stent-grafts, be able to follow up, and consent to participate. Pregnant individuals, those with recent procedures or participation in other trials, severe allergies to contrast material, certain infections or connective tissue disorders are excluded.

What is being tested?

The study tests endovascular repair devices on three groups: one using custom devices for juxtarenal/suprarenal/type IV thoracoabdominal aneurysms; another for type I-III thoracoabdominal aneurysms needing branched/fenestrated devices; and a third group treated with patient-specific stent-grafts for aortic arch aneurysms.

What are the potential side effects?

Potential side effects may include complications from the implantation procedure such as bleeding or infection, allergic reactions to materials used in the stent-graft or contrast dye during imaging studies, damage to blood vessels where the device is placed, and radiation exposure from x-ray imaging.

Eligibility Criteria

Inclusion Criteria

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

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I cannot or will not give my consent to participate.

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I have a blood clotting disorder that cannot be corrected.

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I have a large aneurysm in my chest or abdomen.

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My veins are not suitable for the needed medical procedure.

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

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I am under 18 years old.

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

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

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My body can accommodate a specific device for my heart surgery.

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

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

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My body's structure doesn't allow for the use of the specific medical device due to blockage or small size.

Exclusion Criteria

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

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My aortic dissection does not meet the specific trial criteria.

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My aortic arch condition does not meet the specific criteria mentioned.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluate effectiveness endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices.

Aortic Aneurysm

Secondary study objectives

Number of Major adverse events

Number of participants with adverse events from the use of bare metal stents as a measure of safety

Rate of Grafts deployed at intended site with successful and patent stenting of target vessels (technical success)

Other study objectives

Number of participants with adverse events from radiation exposure as a measure of tolerability.

Rate of complications not considered as major (Secondary safety endpoints)

Medical Devices

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Type I - III TAAA cohortExperimental Treatment1 Intervention

Patients enrolled in this arm will be implanted with the custom made/ off-the-shelfp branched devices. The device is aimed to treat type I-III TAAAs.

Group II: Fenestrated CMD cohortExperimental Treatment1 Intervention

Patients enrolled in this arm will be implanted with the custom made fenestrated device. The device is aimed to treat complex abdominal aortic aneurysms including juxtarenal, suprarenal and type IV thoracoabdominal aneurysms.

Group III: Arch cohortExperimental Treatment1 Intervention

Patients enrolled in this arm will be implanted with patient-specific stent-grafts with one to three inner branches or a scallop.

0 / 14Eligibility 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

Endovascular repair of Abdominal Aortic Aneurysms (AAA) involves the use of stent-grafts, such as Custom-Made Devices (CMDs) and the Zenith Thoracoabdominal Branch Device, which are inserted into the aorta via a catheter. These devices reinforce the weakened section of the aorta, preventing rupture by providing a new path for blood flow that bypasses the aneurysm. This minimally invasive approach reduces the risk of complications and shortens recovery time compared to open surgical repair. For AAA patients, these treatments are crucial as they offer a safer and more effective option, especially for those who are high-risk or have complex aneurysm anatomies.

[Endovascular repair of thoracic aortic aneurysms: toward a new standard of treatment].