Stent-Graft for Aortic Aneurysm

(IDE#2 Trial)

Recruiting at 3 trial locations

Overseen By Ying Huang, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gustavo S. Oderich

Disqualifiers: Pregnancy, Infection, Connective tissue disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: Immediate procedure

760 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new stent-graft device for treating aortic aneurysms, which are dangerous bulges in the main artery that carries blood from the heart. The study involves two types of stent-grafts: one ready-made and another customized for each patient, both designed to fit specific parts of the aorta. It targets individuals with large or fast-growing aortic aneurysms or those at high risk of rupture. Participants should have an aneurysm larger than 5.5 cm or one that has grown significantly over the past year. As an unphased trial, this study offers a unique opportunity to contribute to medical advancements and potentially benefit from innovative treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that participation in certain other clinical trials is restricted, so it's best to discuss your specific medications with the trial team.

What prior data suggests that this stent-graft is safe for aortic aneurysm repair?

Research has shown that the Zenith t-Branch and custom-made stent-grafts are generally safe for treating aortic aneurysms. One study found low rates of death and complications both 30 days and one year after treatment, indicating that patients tolerate these stent-grafts well. The Zenith t-Branch is already used for high-risk patients with certain types of aneurysms, further supporting its safety. Overall, these findings suggest that the stent-grafts used in this trial have proven safe in previous cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new stent-graft treatments for aortic aneurysms because they offer a personalized approach that isn't available with standard options like open surgery or generic endovascular stents. The Zenith t-Branch and customized physician-specified stent-grafts are designed specifically for each patient's anatomy, using a combination of fenestrations and branches to align perfectly with the arteries. This tailored fit can potentially reduce complications and improve outcomes by ensuring that crucial arteries remain open and properly aligned, which is a significant advancement over the more standardized approaches.

What evidence suggests that the Zenith t-Branch and customized stent-graft are effective for aortic aneurysm?

Research has shown that the Zenith t-Branch and customized stent-grafts hold promise for treating aortic aneurysms. In this trial, participants will join one of two study arms. The Aortic Arch Aneurysm Arm includes patients with aortic arch aneurysms treated by patient-specific stent-grafts. The Thoracoabdominal Aortic Aneurysm Arm involves endovascular aortic repair using either an off-the-shelf Zenith t-Branch or a patient-specific stent-graft. Studies have found these devices safe and effective in reducing aneurysm-related problems, with good survival rates at both 30 days and one year post-treatment. The grafts are specially made to fit the patient's body, helping keep arteries open and properly aligned. This customization is crucial for maintaining blood flow to vital organs like the liver and kidneys. Overall, early findings suggest these stent-grafts could reliably manage complex aortic aneurysms. ^{1 2 3 5 6}

Who Is on the Research Team?

Gustavo S. Oderich, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My treatment may include a specific device for my lower torso condition.

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

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

Exclusion Criteria

You are expected to live for less than 2 years.

I need urgent repair for a ruptured aortic aneurysm, but it's stable and fits standard treatment designs.

You are not participating in any other experimental medical or device trials, except for specific trials related to endovascular stent-grafts or other approved medical therapies to reduce risks during fenestrated-branched endovascular repair.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular repair using the Zenith Fenestrated-Branched System to treat aortic aneurysms or dissections

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment success and quality of life measures

12 months

Multiple visits at 30 days, 6 months, 1 year

Long-term Follow-up

Extended monitoring of participants for quality of life and adverse events

5 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Zenith t-Branch and customized physician-specified stent-graft

Trial Overview

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.

How Is the Trial Designed?

Group I: Complex Abdominal (CAAA) and Thoracoabdominal Aortic Aneurysm (TAAA) Arm Experimental Treatment 1 Intervention

The CAAA and TAAA study arm will include 700 patients treated by endovascular aortic repair of CAAAs and TAAAs (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, with or without concomitant unilateral or bilateral iliac artery aneurysms treated by iliac branch devices. 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 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 Arm Experimental Treatment 1 Intervention

Aortic Arch study arm will include 60 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 CAAAs, TAAAs 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.

Zenith t-Branch and customized physician-specified stent-graft is already approved in European Union, United States for the following indications:

Approved in European Union as Zenith t-Branch Thoracoabdominal Endovascular Graft for:

• Thoracoabdominal aortic aneurysms

Approved in United States as Zenith t-Branch Thoracoabdominal Endovascular Graft for:

• Thoracoabdominal aortic aneurysms

Who Is Running the Clinical Trial?

Gustavo S. Oderich

Lead Sponsor

Trials

1

Recruited

530+

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Gustavo Oderich

Lead Sponsor

Trials

2

Recruited

730+

William Cook Australia

Industry Sponsor

Trials

5

Recruited

1,200+

Published Research Related to This Trial

In a study of 80 patients treated with the Zenith t-Branch stent-graft for thoracoabdominal aortic aneurysms, the device demonstrated a low 30-day mortality rate of 1.3% and a 1-year mortality rate of 8.8%, indicating its safety in both stable and symptomatic cases.

Despite some complications, including a high rate of postoperative endoleaks (51.4% at 30 days), the main body graft showed 100% patency at 1 year, suggesting effective long-term device integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft. Bosiers, M., Kölbel, T., Resch, T., et al.[2022]

In a study of 45 patients with thoraco-abdominal aortic aneurysms, both the multibranched Zenith t-Branch stent graft and custom-made devices showed low 30-day mortality rates (4%) and similar technical success rates (87%), indicating both options are safe and effective.

Medium-term survival rates were high, with 93% of t-Branch patients and 100% of CMD patients surviving at one year, and no significant differences in complications like paraparesis or paraplegia between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm Outcomes for Endovascular Repair of Thoraco-Abdominal Aortic Aneurysms. Ulsaker, H., Seternes, A., Brekken, R., et al.[2022]

The t-Branch stent graft is an effective off-the-shelf solution for treating rapidly expanding thoracoabdominal aortic aneurysms, allowing for intraoperative customization to accommodate individual patient anatomy.

In a case study involving a 66-year-old woman, the t-Branch stent graft successfully excluded the aneurysm sac and resulted in nearly complete shrinkage of the sac after 12 months, demonstrating its efficacy in urgent situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular repair of thoracoabdominal aortic aneurysm using the off-the-shelf multibranched t-Branch stent graft. Mendes, BC., Oderich, GS.[2017]

Fenestrated and branched aortic endografts, like the Zenith T-Branch device, have improved treatment options for patients with extensive thoracoabdominal aortic aneurysms (TAAAs) by allowing for aneurysm exclusion while preserving blood flow to vital organs.

The development of 'off-the-shelf' grafts, such as the Zenith T-Branch, aims to provide quicker treatment options for patients in need, although long-term outcomes regarding their effectiveness and safety are still being studied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update of T-branch use from the US Aortic Research Consortium. Khoury, MK., Lancaster, E., Eagleton, MJ., et al.[2023]

The off-the-shelf multibranched Zenith t-Branch endograft demonstrated a technical success rate of 82% in urgent thoracoabdominal aortic aneurysm (TAAA) repairs, indicating it is a viable option when custom-made grafts are not available.

Despite some complications, including a 6% 30-day mortality rate and temporary spinal cord ischemia in 6% of patients, the endograft showed promising long-term outcomes with no TAAA-related mortality and 82% freedom from reintervention at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-the-shelf multibranched endograft for urgent endovascular repair of thoracoabdominal aortic aneurysms. Gallitto, E., Gargiulo, M., Freyrie, A., et al.[2018]

In a study of 80 patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair with the Zenith t-Branch graft, technical success was achieved in 98.8% of cases, demonstrating the efficacy of this endovascular approach.

At 24 months, the study reported high rates of target vessel patency, with 94.8% for primary patency and 96.3% for secondary patency, indicating durable outcomes and safety in managing TAAA with this graft.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms. Tsilimparis, N., Bosiers, M., Resch, T., et al.[2023]

A 72-year-old man successfully underwent treatment for a symptomatic type Ia endoleak using the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft, demonstrating its efficacy in managing complex vascular issues after previous stent-graft procedures.

Ten months post-procedure, imaging showed a reduction in sac diameter and no signs of endoleak, indicating that the Zenith t-Branch device is a promising option for treating proximal endoleaks in patients with bifurcated stent-grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Off-the-Shelf t-Branch Device to Treat an Acute Type Ia Endoleak in a Symptomatic Juxtarenal Abdominal Aortic Aneurysm. Khanafer, A., Khashram, M., Ruiz, CM., et al.[2016]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT02089607

Complex Abdominal, TAAA, Aortic Arch Aneurysm or ...

The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11676123/

Endovascular Repair of Spontaneous Rupture of Stent Graft ...

We present the case of an 82-year-old male with a thoracoabdominal aortic aneurysm treated with endovascular aneurysm repair using the Zenith t-Branch.

3.

mayo.edu

mayo.edu/research/clinical-trials/diseases-conditions/thoracic-aortic-aneurysm

Thoracic Aortic Aneurysm Clinical Trials

The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of ...

4.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.068587

Multicenter Study on Physician-Modified Endografts for ...

Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft. J Vasc Surg. 2021;74 ...

5.

jvascsurg.org

jvascsurg.org/article/S0741-5214(21)00323-2/fulltext

Early and midterm results from a postmarket observational ...

The t-Branch device appears safe, with good 30-day and 1-year mortality and morbidity in the present study, including both stable and ...

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cookmedical.eu

cookmedical.eu/products/b50ed018-b896-4645-b24f-853a12dfff2c/

Zenith® t-Branch® Thoracoabdominal Endovascular Graft

The Zenith t-Branch Thoracoabdominal Endovascular Graft is indicated for the endovascular treatment of high-risk patients with thoracoabdominal aneurysms.