Endograft for Aortic Aneurysm

Recruiting at 1 trial location

Overseen By Lisamarie Kernicky, RN;BSN;CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lee, W. Anthony, M.D. FACS

Disqualifiers: Pregnancy, Untreatable malignancy, Severe infection, 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: 2

Duration: Immediate

235 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing special medical devices called stent-grafts to help patients with specific aortic conditions that are hard to treat with regular methods. The devices strengthen the aorta to prevent it from breaking. Stent-grafts have been developed as an alternative to surgery for treating various thoracic aortic diseases, including aneurysms, ulcers, and dissections.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Zenith t-Branch Endovascular Stent-Graft System safe for humans?

The Zenith t-Branch Endovascular Stent-Graft System has been studied for safety in humans, showing low periprocedural mortality (death related to the procedure) under 2% in healthy patients and a low risk of complications like endoleaks (leakage around the graft) and device migration. Design improvements have addressed previous issues, enhancing the device's safety. ^{1 2 3 4 5}

How is the Zenith t-Branch treatment different from other treatments for aortic aneurysm?

The Zenith t-Branch treatment is unique because it uses a branched endovascular stent-graft system, which allows for precise placement and reduced risk of rotation during the repair of aortic aneurysms. This approach is particularly beneficial for complex aneurysms that involve branches of the aorta, offering a tailored fit without the need for custom-made devices. ^{1 4 6 7 8}

Research Team

W. Anthony Lee, MD

Principal Investigator

Lynn Heart and Vascular Institute, Boca Raton Regional Hospital

Eligibility Criteria

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.

Inclusion Criteria

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

My leg arteries are too narrow or blocked for standard access.

Exclusion Criteria

You are expected to live for less than a year.

Pregnant or breastfeeding or planning on becoming pregnant within 60 months

The angle between the neck and the aneurysm is less than 90 degrees.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive endovascular treatment with the investigational Zenith t-Branch or Terumo Arch Branch Endovascular Graft

Immediate

1 visit (in-person)

Early Follow-up

Participants are monitored for early mortality and stroke after branch endograft treatment

4 weeks

1 visit (in-person)

Late Follow-up

Participants are monitored for neurologic complications, late branch vessel patency, and other secondary outcomes

60 months

Treatment Details

Interventions

• Zenith® t-Branch

Trial Overview 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.

Participant Groups

Group I: Single Treatment Arm-Zenith t-Branch Cohort Experimental Treatment 1 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 Cohort Experimental Treatment 1 Intervention

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

Zenith® t-Branch is already approved in United States, European Union for the following indications:

Approved in United States as Zenith t-Branch for:

• Thoracic aortic aneurysms
• Thoracic aortic dissections

Approved in European Union as Zenith t-Branch for:

• Thoracic aortic aneurysms
• Thoracic aortic dissections
• Penetrating aortic ulcers
• Intramural hematomas

Who Is Running the Clinical Trial?

Lee, W. Anthony, M.D. FACS

Lead Sponsor

Trials

1

Recruited

240+

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

Bolton Medical

Industry Sponsor

Trials

17

Recruited

2,900+

William Cook Australia

Industry Sponsor

Trials

5

Recruited

1,200+

Findings from Research

The Zenith endovascular grafting system was successfully implanted in 524 out of 528 patients with infrarenal abdominal aortic aneurysms, demonstrating its efficacy in high-risk patients, with a follow-up period averaging 18 months.

The overall endoleak rate was 15%, with only 4% requiring urgent treatment, indicating that while complications can occur, the risks of significant issues or aneurysm rupture are relatively low for properly selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update of the Zenith endovascular graft for abdominal aortic aneurysms: initial implantation and mid-term follow-up data. Greenberg, RK., Lawrence-Brown, M., Bhandari, G., et al.[2019]

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]

The Zenith endovascular graft demonstrated long-term safety and efficacy over a 5-year follow-up period, with low rates of aneurysm-related death (2% for standard-risk and 4% for high-risk patients) and a 100% freedom from rupture in both risk groups.

Complications such as migration, limb occlusion, and device integrity issues were rare (less than or equal to 3%), but the incidence of late endoleaks (12% to 15%) highlights the importance of ongoing monitoring for patients with endovascular grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zenith abdominal aortic aneurysm endovascular graft. Greenberg, RK., Chuter, TA., Cambria, RP., et al.[2012]

The Zenith stent-graft demonstrated a high technical success rate of 98.3% in elective abdominal aortic aneurysm repairs among 234 patients, indicating its effectiveness as a treatment option.

With a low 30-day mortality rate of 1.7% and a 5-year overall survival rate of 69.9%, the procedure shows promising safety and efficacy, along with a low re-intervention rate of 9.2% during a median follow-up of 26.9 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of endovascular abdominal aortic aneurysm repair with the Zenith stent-graft. Bos, WT., Tielliu, IF., Zeebregts, CJ., et al.[2022]

The Zenith endovascular graft, designed for treating infrarenal abdominal aortic aneurysms, has shown a periprocedural mortality rate of under 2% in healthy patients, indicating a high level of safety when used according to guidelines.

Long-term data suggest that the majority of aneurysms treated with this device shrink over 1 to 2 years, with a low incidence of complications such as endoleaks (7.4% at 12 months) and no migration observed in patients over 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Zenith AAA endovascular graft. Kaviani, A., Greenberg, RK.[2005]

The sequential deployment technique of the Zenith® t-Branch™ device for aortic aneurysm repair allows for better control and positioning, reducing the risk of device rotation during the procedure.

Using live CT-fusion and intravascular ultrasound guidance, this method enhances the accuracy of catheterizing target arteries, ensuring effective and stable deployment of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential Catheterization and Progressive Deployment of the Zenith® t-Branch™ Device for Branched Endovascular Aortic Aneurysm Repair. Malekpour, F., Scott, CK., Kirkwood, ML., et al.[2021]

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]

In a study of 206 patients with abdominal aortic aneurysms, the Zenith stent-graft showed a low 30-day mortality rate of 2.9% and no deaths due to aneurysm rupture, indicating its safety in midterm use.

The stent-graft demonstrated an 83% rate of freedom from repeat vascular interventions over 5 years, highlighting its efficacy and reliability in preventing complications after endovascular repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finnish multicenter study on the midterm results of use of the Zenith stent-graft in the treatment of an abdominal aortic aneurysm. Nevala, T., Biancari, F., Manninen, H., et al.[2009]

References

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

An update of the Zenith endovascular graft for abdominal aortic aneurysms: initial implantation and mid-term follow-up data. [2019]

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

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

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

Zenith abdominal aortic aneurysm endovascular graft. [2012]

4. England pubmed.ncbi.nlm.nih.gov

Results of endovascular abdominal aortic aneurysm repair with the Zenith stent-graft. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Zenith AAA endovascular graft. [2005]

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

Sequential Catheterization and Progressive Deployment of the Zenith® t-Branch™ Device for Branched Endovascular Aortic Aneurysm Repair. [2021]

7. 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]

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

Finnish multicenter study on the midterm results of use of the Zenith stent-graft in the treatment of an abdominal aortic aneurysm. [2009]