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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.

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 data supports the effectiveness of the treatment Fenestrated Stent Graft for Abdominal Aortic Aneurysm?

The Zenith Fenestrated Endovascular Graft (ZFEN) is associated with lower short-term complications and death rates compared to traditional open surgery for complex abdominal aortic aneurysms. Additionally, a case study showed successful treatment of a complex aneurysm with no complications after one year. ^{1 2 3 4 5}

Is the Fenestrated Stent Graft for Abdominal Aortic Aneurysm safe for humans?

The Zenith Fenestrated Endovascular Graft (ZFEN) is generally considered safe for treating abdominal aortic aneurysms, with studies showing it can reduce complications compared to open surgery, though it is a complex procedure with some risk of device-related issues. ^{1 2 3 6 7}

What makes the Zenith Fenestrated AAA Endovascular Graft treatment unique for abdominal aortic aneurysm?

The Zenith Fenestrated AAA Endovascular Graft is unique because it is a custom-made device designed to fit the specific anatomy of each patient, allowing it to treat complex abdominal aortic aneurysms that are close to the renal arteries. This personalized approach can reduce the risk of complications and improve outcomes compared to traditional open surgery. ^{1 2 3 4 8}

Research Team

Gustavo Oderich, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2019]

2. United States 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. [2019]

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

Maximizing proximal seal zone in fenestrated endografting: Evolution in the approach to graft configuration. [2021]

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

Technical aspects of repair of juxtarenal abdominal aortic aneurysms using the Zenith fenestrated endovascular stent graft. [2016]

5. United States 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. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Superior mesenteric artery outcomes after large fenestration strut relocation with the Zenith Fenestrated endoprosthesis. [2020]

7. United States 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. [2014]

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

Outcomes of fenestrated endografts in the treatment of abdominal aortic aneurysm in Western Australia (1997-2004). [2022]