Fenestrated Stent Graft for Abdominal Aortic Aneurysm

(IDE#1 Trial)

Recruiting at 1 trial location

Overseen By Safa Savadi Osgouei, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, Pregnant, Life expectancy < 2 years, 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: 1

Duration: 6 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of stent graft, the Cook Zenith® Fenestrated AAA Endovascular Graft, for treating certain large or fast-growing aortic aneurysms (ballooning of the artery wall). The goal is to evaluate how effectively this custom-made device maintains blood flow and enhances patients' quality of life. Individuals with an aortic aneurysm at least twice the normal size or growing rapidly may be suitable candidates for this trial. As an unphased trial, it provides patients the chance to contribute to innovative research that could enhance future treatments.

Will I have to stop taking my current medications?

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 the Zenith Fenestrated AAA Endovascular Graft is safe for endovascular aortic repair?

Research has shown that the custom-made Zenith® Fenestrated AAA Endovascular Graft is generally well-tolerated. In a study with 67 patients, the graft produced positive results over five years, indicating its safety for treating abdominal aortic aneurysms, which are bulges in the large artery in the abdomen. The graft maintains proper blood flow by using small openings or branches to connect with important arteries.

Previous findings indicate that the graft was effective in many cases, achieving successful technical outcomes. While any medical procedure carries risks, these studies suggest this graft is a safe option for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Zenith® Fenestrated AAA Endovascular Graft because it offers a customized approach to treating complex abdominal aortic aneurysms. Unlike standard options, which may not perfectly fit the unique anatomy of every patient's blood vessels, this graft is specifically designed with tiny holes or branches to accommodate vital arteries, such as those leading to the liver, intestines, and kidneys. This personalization helps ensure that the blood continues to flow properly through these critical areas, potentially reducing the risk of complications and improving outcomes for patients with challenging aneurysms.

What evidence suggests that the Zenith Fenestrated AAA Endovascular Graft is effective for abdominal aortic aneurysm?

Research has shown that the Zenith Fenestrated AAA Endovascular Graft, which participants in this trial will receive, effectively treats certain aortic aneurysms. In one study, 91% of patients survived after five years, and 79% experienced no major issues related to the treatment. The graft successfully kept the arteries to the kidneys open in 81% of cases. These results suggest the graft effectively manages complex aneurysms by maintaining open and properly aligned blood vessels. The study also found no deaths related to the graft or aneurysms over five years, highlighting its safety and effectiveness. ^{1 3 6 7 8}

Who Is on the Research Team?

Gustavo Oderich, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults with complex abdominal aortic aneurysms, specifically juxtarenal, suprarenal, or type IV thoracoabdominal types that are at high risk of rupture. Candidates should have aneurysms ≥5.0 cm or twice the normal size, or those growing ≥0.5 cm per year. Excluded are individuals under 18, pregnant/breastfeeding women, those unwilling to follow up, with less than 2 years life expectancy or other medical/anatomical restrictions.

Inclusion Criteria

My aneurysm has grown at least 0.5 cm in a year.

I have a large aneurysm near my kidney or chest suitable for a specific graft treatment.

My doctor thinks my aneurysm is at high risk of bursting.

Exclusion Criteria

You are not expected to live for more than 2 years.

Additional anatomical restrictions as specified in the Clinical Investigation Plan

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular aortic repair using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of major adverse events and treatment success

12 months

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants' quality of life is assessed using the SF-36 questionnaire over several years

5 years

Annual visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Custom-made Zenith® Fenestrated AAA Endovascular Graft

Trial Overview The study tests the effectiveness and quality of life impact of using custom-made Cook Zenith® Fenestrated AAA Endovascular Grafts in repairing complex abdominal aortic aneurysms close to the kidneys and above.

How Is the Trial Designed?

Group I: Endovascular Experimental Treatment 1 Intervention

The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, 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. Other names: Endovascular stent Stent-graft

Custom-made Zenith® Fenestrated AAA Endovascular Graft is already approved in United States, European Union for the following indications:

Approved in United States as Zenith Fenestrated AAA Endovascular Graft for:

• Infrarenal abdominal aortic aneurysms (AAAs) in high-risk patients who are not suitable for conventional open surgical repair or who are not suitable for repair with a standard Zenith Endovascular Graft, when the aneurysmal disease extends up to the level of the renal arteries.

Approved in European Union as Zenith Fenestrated AAA Endovascular Graft for:

• Infrarenal abdominal aortic aneurysms (AAAs) in high-risk patients who are not suitable for conventional open surgical repair or who are not suitable for repair with a standard Zenith Endovascular Graft, when the aneurysmal disease extends up to the level of the renal arteries.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Gustavo Oderich

Lead Sponsor

Trials

2

Recruited

730+

Cook Group Incorporated

Industry Sponsor

Trials

92

Recruited

15,500+

Carl Cook

Cook Group Incorporated

Chief Executive Officer since 2011

Bachelor's degree in Engineering from Purdue University, MBA from the University of Iowa

Dr. John A. Kaufman

Cook Group Incorporated

Chief Medical Officer since 2023

MD

Published Research Related to This Trial

The Zenith fenestrated endovascular graft demonstrated a 100% technical success rate in treating juxtarenal abdominal aortic aneurysms in a study of 67 patients across 14 centers, with low postoperative mortality (1.5%) and no aneurysm ruptures during a mean follow-up of 37 months.

At 5 years, the study reported a high patient survival rate of 91% and a low rate of major adverse events (21%), indicating that this treatment is both safe and effective for properly selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of the United States multicenter prospective study evaluating the Zenith fenestrated endovascular graft for treatment of juxtarenal abdominal aortic aneurysms. Oderich, GS., Greenberg, RK., Farber, M., et al.[2014]

Between April 2012 and August 2015, the Zenith fenestrated endovascular graft (ZFEN) saw a remarkable 911% increase in monthly orders, indicating growing adoption among trained physicians, with 388 out of 553 trained physicians ordering a total of 2669 devices.

Despite the increase in orders, a significant number of trained physicians (30%) did not order any devices, and 81% ordered five or fewer per year, suggesting that the use of this complex technology may be better suited for high-volume centers to ensure optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in use of the only Food and Drug Administration-approved commercially available fenestrated endovascular aneurysm repair device in the United States. Simons, JP., Shue, B., Flahive, JM., et al.[2019]

Over 5 years, 744 surgeons were trained to use the Zenith fenestrated (Z-Fen) endograft, resulting in 4133 cases performed, indicating a growing but slow adoption of this advanced treatment for aortic aneurysms.

Surgeons at academic centers and those trained early in the product's availability were more likely to use Z-Fen frequently, suggesting that targeted training and referral patterns could enhance its utilization in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice Patterns of Fenestrated Aortic Aneurysm Repair: Nationwide Comparison of Z-Fen Adoption at Academic and Community Centers Since Commercial Availability. Wiske, C., Lee, JT., Rockman, C., et al.[2018]

The Zenith fenestrated stent graft system is a custom-designed device approved for treating complex aortic aneurysms, specifically for patients with short-neck infrarenal and juxtarenal abdominal aortic aneurysms.

In a case study of an 80-year-old female patient, the stent graft was successfully implanted using a totally percutaneous approach, resulting in no complications and a follow-up CT scan at 12 months showing no endoleak or graft issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical aspects of repair of juxtarenal abdominal aortic aneurysms using the Zenith fenestrated endovascular stent graft. Oderich, GS., Correa, MP., Mendes, BC.[2016]

In a study of 58 patients with abdominal aortic aneurysms treated with fenestrated endovascular endografts, the treatment success rate was high at 94.8%, indicating effective aneurysm exclusion without major complications.

While the 30-day mortality rate was 3.4%, the findings suggest that fenestrated endografts provide a viable option for patients with challenging anatomical features, although there may be a trend toward higher mortality compared to standard repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of fenestrated endografts in the treatment of abdominal aortic aneurysm in Western Australia (1997-2004). Semmens, JB., Lawrence-Brown, MM., Hartley, DE., et al.[2022]

The Zenith Fenestrated Endovascular Graft (ZFEN) shows significantly lower rates of perioperative mortality (1.8% vs 8.8%) and postoperative renal dysfunction (1.4% vs 7.7%) compared to open complex abdominal aortic aneurysm (AAA) repair, based on a study of 6825 AAA repairs.

When compared to standard infrarenal endovascular aneurysm repair (EVAR), ZFEN has similar rates of perioperative mortality and complications, indicating it is a safe and effective alternative for complex AAAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated endovascular aneurysm repair is associated with lower perioperative morbidity and mortality compared with open repair for complex abdominal aortic aneurysms. Varkevisser, RRB., O'Donnell, TFX., Swerdlow, NJ., et al.[2019]

Using a fenestrated endograft configuration with a large fenestration for the superior mesenteric artery (SMA) and two small fenestrations for the renal arteries significantly increases the proximal seal length, which can help prevent complications like type IA endoleaks.

In a study of 100 patients, the new configuration (B) was associated with a 5.8 mm gain in seal zone length compared to the traditional configuration (A), and type IA endoleaks were resolved without intervention in all cases, indicating a safe and effective approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing proximal seal zone in fenestrated endografting: Evolution in the approach to graft configuration. Newton, DH., Etkin, Y., Foley, PJ., et al.[2021]

In a study of 121 patients undergoing fenestrated endovascular repair with the Zenith® Fenestrated stent-graft, relocating struts for superior mesenteric artery (SMA) incorporation did not negatively affect procedural success or midterm outcomes, with an overall technical success rate of 99%.

Patients with strut relocation experienced lower operative times and reduced contrast volume and radiation exposure, suggesting that this approach may enhance procedural efficiency without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior mesenteric artery outcomes after large fenestration strut relocation with the Zenith Fenestrated endoprosthesis. Mirza, AK., Sullivan, TM., Skeik, N., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32891806/

Final 5-year results of the United States Zenith Fenestrated ... These 5-year results confirm the safety and effectiveness of the Zenith Fenestrated AAA stent graft with no late graft- or aneurysm-related deaths.

2. jvascsurg.org jvascsurg.org/article/S0741-5214(20)32014-0/fulltext

Final 5-year results of the United States Zenith Fenestrated ... This report summarizes the final 5-year results of 67 patients enrolled in the Zenith Fenestrated (ZFEN) multicenter study designed to evaluate ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf2/p020018s040b.pdf

Summary of Safety and Effectiveness Data - accessdata.fda.gov Table 22 reports the technical success results for the Zenith. Fenestrated AAA Endovascular Graft. Table 22. Technical success. Measure.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0741521414016279

Results of the United States multicenter prospective study ... At 5 years, patient survival was 91% ± 4%, and freedom from major adverse events was 79% ± 6%; primary and secondary patency of targeted renal arteries was 81% ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19786236/

Intermediate results of a United States multicenter trial ... Objective: This article reports the intermediate-term (24-month) outcomes of a prospective multicenter trial designed to evaluate the Zenith Fenestrated AAA ...

6. ifu.cookmedical.com ifu.cookmedical.com/data/IFU_PDF/IFU-FU_V3.PDF

Zenith® Fenestrated AAA Endovascular Graft Graft in the treatment of abdominal aortic aneurysms in patients with short ... The primary safety and effectiveness data showed that the 6-month.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01937949

Study Details | NCT01937949 | Complex Abdominal Aortic ... The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, ...

8. nm.org nm.org/conditions-and-care-areas/treatments/minimally-invasive-aortic-valve-repair-zenith-fenestrated-aaa-endovascular-grafts

Zenith Fenestrated AAA Endovascular Grafts The Zenith Fenestrated AAA endovascular graft allows vascular surgeons to repair abdominal aortic aneurysms near the kidneys with better clinical outcomes.