Stent-Graft for Aortic Aneurysm

(IDE#2 Trial)

Recruiting at 1 trial location

Overseen By Safa Savadi Osgouei, MD

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

530 Participants Needed

Trial Summary

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 data supports the idea that Stent-Graft for Aortic Aneurysm is an effective treatment?

The available research shows that the Stent-Graft for Aortic Aneurysm, specifically the Zenith t-Branch, is effective in treating thoracoabdominal aortic aneurysms. Studies report positive early and midterm results, indicating that the treatment is safe and maintains blood flow in the targeted vessels for up to two years. This suggests that the Stent-Graft is a reliable option for managing this condition. ^{1 2 3 4 5}

What safety data is available for the Zenith t-Branch stent-graft used in aortic aneurysm treatment?

The safety data for the Zenith t-Branch stent-graft includes early and midterm results from various studies. A postmarket observational study reported short-term safety outcomes of the Zenith t-Branch multibranched thoracoabdominal stent-graft. Another study investigated midterm technical and clinical outcomes for patients treated with the Zenith t-Branch or a custom-made device. Additionally, a study assessed two-year clinical outcomes and target vessel patency following thoracoabdominal aortic aneurysm repair with the Zenith t-Branch. Early and midterm results were also reported for urgent repairs using the Zenith t-Branch endograft. ^{1 2 3 4 5}

Is the treatment Zenith t-Branch and customized physician-specified stent-graft a promising treatment for aortic aneurysm?

Yes, the Zenith t-Branch and customized physician-specified stent-graft is a promising treatment for aortic aneurysm. It offers a quick and effective solution for patients with complex aortic conditions, especially those needing urgent care. The device is designed to fit many patients without the long wait for a custom-made option, and early results show it successfully treats the aneurysm while keeping important blood vessels open. ^{1 2 3 6 7}

What is the purpose of this trial?

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 fenestrations and/or branches to repair aortic aneurysm.

Research Team

Gustavo S. Oderich, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Thoracoabdominal Aortic Aneurysm Arm Experimental Treatment 1 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 Arm Experimental Treatment 1 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.

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+

Gustavo Oderich

Lead Sponsor

Trials

2

Recruited

730+

William Cook Australia

Industry Sponsor

Trials

5

Recruited

1,200+

Findings from Research

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]

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]

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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Midterm Outcomes for Endovascular Repair of Thoraco-Abdominal Aortic Aneurysms. [2022]

2. United States 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. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Off-the-shelf multibranched endograft for urgent endovascular repair of thoracoabdominal aortic aneurysms. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft. [2022]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Italy pubmed.ncbi.nlm.nih.gov

Update of T-branch use from the US Aortic Research Consortium. [2023]