What side effects are associated with this type of intervention?

The most common treatments for Thoracoabdominal Aortic Aneurysms (TAAAs) using endovascular stent-graft systems can lead to several side effects. These include procedure-related mortality and morbidity, endoleaks (persistent blood flow into the aneurysm sac), and issues with device integrity such as migration, infolding, or collapse of the stent-graft. Postoperative complications may include stroke, spinal cord ischemia, and extremity ischemia. Additionally, there is a risk of needing secondary interventions due to complications like endoleaks or device migration. Regular follow-up with imaging is necessary to monitor for these potential issues.

What prior FDA approvals exist?

The FDA has approved several endovascular stent-graft systems for the treatment of thoracoabdominal aortic aneurysms. These devices, such as the Cook Zenith t-Branch and the Terumo Arch Branch, are designed to reinforce the vessel wall and exclude the aneurysm from blood flow, thereby preventing rupture. These stent-grafts offer a minimally invasive alternative to traditional open surgical repair, reducing recovery time and associated risks.

What other types of research exist?

Promising novel alternatives to Endovascular Stent-Graft Systems for TAAA treatment in 2024 include hybrid surgical and endovascular procedures, which involve debranching of the aortic arch and the use of multi-branched prostheses. These techniques aim to enhance the durability and effectiveness of the repair while minimizing invasiveness and recovery time.

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Endovascular Stent-Graft System

Endograft for Aortic Aneurysm

N/A

Recruiting

Led By W. Anthony Lee, MD

Research Sponsored by Lee, W. Anthony, M.D. FACS

Eligibility Criteria Checklist

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

Must have

The patient must have one of the following: Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular) with a diameter of ≥55mm in a male or ≥50mm in a female, or Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or Penetrating ulcers with a depth of ≥20mm, or Chronic type B aortic dissections with a total aortic diameter of ≥50mm, or Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.

Be older than 18 years old

Must not have

Inability to insert the Zenith® t-Branch device through iliofemoral approach

Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0-day 30 (early) day 31-1825 (late)

Awards & highlights

Summary

This trial will help researchers learn more about the safety and effectiveness of the Cook Zenith t-Branch endovascular stent-graft system for treating aortic aneurysms.

Who is the study for?

This trial is for adults with certain types of aortic aneurysms, including those that are large, growing quickly, or symptomatic. Participants need to have specific measurements related to their aneurysm and access vessels. Excluded are individuals under 18, pregnant women, those with short life expectancy or uncontrollable allergies to contrast dye.Check my eligibility

What is being tested?

The study is evaluating the Zenith t-Branch endovascular stent-graft system in treating aortic aneurysms. It aims to gather data on its effectiveness and safety when used in real-world medical settings.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include complications from the device such as blood vessel damage during insertion, movement of the graft after placement, leakage around the graft (endoleak), blockage or infection.

Eligibility Criteria

Inclusion Criteria

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

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I have a specific type of large or growing aortic aneurysm, ulcer, or dissection.

Exclusion Criteria

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

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The Zenith® t-Branch device cannot be inserted in me through the iliofemoral approach.

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I have an abnormal connection between my aorta and another organ.

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I am under 18 years old.

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I do not have an untreated or uncontrolled infection.

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I have an infection caused by fungi.

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My cancer cannot be cured with treatment.

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I refuse to receive blood transfusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0-day 30 (early) day 31-1825 (late)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0-day 30 (early) day 31-1825 (late)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0-day 30 (early) day 31-1825 (late) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Early Mortality & Stroke

Secondary outcome measures

Rates of Neurologic Complications/Late Branch Vessel Patency

Trial Design

2Treatment groups

Experimental Treatment

Group I: Single Treatment Arm-Zenith t-Branch CohortExperimental Treatment1 Intervention

Zenith t-Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.

Group II: Single Treatment Arm-Terumo Arch Branch CohortExperimental Treatment1 Intervention

Terumo Arch Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Terumo Arch Branch Endovascular Graft.

0 / 8Eligibility 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 stent-graft systems treat Thoracoabdominal Aortic Aneurysms (TAAAs) by reinforcing the vessel wall and excluding the aneurysm from blood flow. The stent-graft is delivered via a catheter and expanded at the aneurysm site, creating a new pathway for blood that bypasses the weakened aneurysm wall, reducing rupture risk. This minimally invasive approach is crucial for TAAA patients, offering a safer alternative to open surgery, particularly for those with significant comorbidities.

Endovascular repair of thoracoabdominal aortic aneurysms using fenestrated and branched endografts.