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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new endovascular graft systems for treating aortic aneurysms, which are dangerous bulges in the aorta, the body's main artery. One study group will use the Zenith® t-Branch graft (also known as the Zenith t-Branch Endovascular Stent-Graft System), while the other will use the Terumo Arch Branch graft, each targeting different parts of the aorta. The trial seeks participants with serious aortic issues, including large aneurysms, ulcers, or chronic dissections (tears in the aorta). Individuals deemed unsuitable for traditional surgery due to high risks might be a good fit. As an unphased trial, this study offers a unique opportunity to access innovative treatments not yet widely available.

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.

What prior data suggests that these endografts are safe for treating aortic aneurysms?

Research shows that the Zenith t-Branch device is generally safe for treating aortic aneurysms. Studies have found good survival rates at both 30 days and one year after the procedure, indicating that patients typically do well shortly after treatment and continue to do well over time. The device is also suitable for those with other health problems that make surgery riskier.

Regarding the Terumo Arch Branch device, research indicates promising results. Studies show it can be performed successfully in most cases. Additionally, the 30-day survival rate after treatment is acceptable, even for patients with higher risks.

Both devices are generally well-tolerated, with few serious side effects reported, making them usually safe for people considering this treatment for aortic issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Zenith® t-Branch Endovascular Graft and the Terumo Arch Branch Endovascular Graft because these treatments offer innovative approaches to managing aortic aneurysms. Unlike traditional open surgery, which requires a large incision and longer recovery time, these grafts are implanted using a minimally invasive endovascular technique. This approach reduces recovery time and the risk of complications. Additionally, the customized design of these grafts allows for a better fit in complex aortic anatomies, potentially improving patient outcomes compared to standard endovascular repair methods.

What evidence suggests that this trial's treatments could be effective for aortic aneurysms?

Research shows that the Zenith t-Branch endograft, which participants in this trial may receive, holds promise for treating complex aortic aneurysms. Studies have found it effective, with good short-term and midterm results, including low rates of death and complications. Patients treated with this device have experienced successful repairs that remain stable over time.

For the Terumo Arch Branch endograft, another treatment option in this trial, studies also report positive outcomes. Research indicates a high success rate during procedures, with some follow-up studies showing 100% success and good blood flow in vessels over time. These findings suggest that both treatments effectively manage challenging aortic conditions. ^{2 4 6 7 8}

Who Is on the Research Team?

W. Anthony Lee, MD

Principal Investigator

Lynn Heart and Vascular Institute, Boca Raton Regional Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9277010/

RELAYTM Branched–International Results of Vessel ... Technical success was achieved in 147 (99.3%) cases. Over 24 months period, target vessel patency was maintained in 80.2% (n = 118) of patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949912724001120

Arch Branch Devices and Clinical Trials in Treatment of ... A follow-up study of 27 patients performed in three European aortic centers continued to show improved results, with a 100% technical success rate and a 30-day ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01524211

Evaluation of Branch Endografts in the Treatment of Aortic ... Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo ...

4. annalsofvascularsurgery.com annalsofvascularsurgery.com/article/S0890-5096(23)00096-1/fulltext

Driving Technology for Thoracic Endovascular Aortic Repair A total of 125 patients were included, out of which 17 (13.6%) received the single-branch RELAY and 108 the double-branch device. In the single- ...

5. ejves.com ejves.com/article/S1078-5884(22)00506-8/pdf

Midterm Outcomes of Endovascular Repair of Aortic Arch ... Conclusion: Initial three year results of the TBE device for endovascular repair of arch aneurysms show favourable patency and durability with ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200045S002B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of endovascular repair of fusiform ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10000330/

Branched and Fenestrated Aortic Endovascular Grafts - PMC This review summarizes the current state of branched, fenestrated, and physician-modified endografts used in complex aortic pathologies.

8. jvascsurg.org jvascsurg.org/article/S0741-5214(25)01555-1/fulltext

Early outcomes of endovascular repair of aortic arch ... Patients had a mean age of 70.8 ± 10.8 years; 66.2% were male and 57.1% White. All patients had both the aortic and side branch (SB) components ...