Modified Stent Grafts for Aortic Aneurysm

(Assets Trial)

Overseen By Jesse Manunga, MD, FSVS, FACS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jesse Manunga, MD

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Pregnancy, Unstable angina, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: Acute phase

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a new type of modified stent graft for individuals with complex aortic aneurysms (a bulge in the wall of the aorta, the body’s main artery). Surgeons modify the stent grafts in this trial using the Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft, and Zenith Flex). The trial targets those whose previous aneurysm repairs failed or who have complex aneurysms in various parts of the aorta. It will compare two groups: individuals with thoracoabdominal aneurysms and those with certain other types of failed repairs. Potential participants include those with previous failed aortic repairs or complex aortic aneurysms that cause symptoms or risk rupture. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for complex aneurysms.

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 team or your doctor.

What prior data suggests that these modified stent grafts are safe for treating complex aortic aneurysms?

Research shows that surgeon-modified fenestrated stent grafts, such as those using the Cook Zenith Platform, are generally safe for treating complex aortic aneurysms. Studies have found these grafts to be both effective and safe for patients with complex aneurysms, offering a reliable option compared to custom-made devices, particularly in urgent situations.

Previous research suggests that these grafts are well-tolerated in the short term. However, some studies note that the quality of evidence can vary, so patients should discuss potential risks and benefits with their healthcare providers. Overall, these grafts have demonstrated a good safety record so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these modified stent grafts because they offer a tailored approach to treating aortic aneurysms. Unlike traditional stent grafts, these surgeon-modified versions can be customized to fit the unique anatomy of each patient, potentially improving the seal and reducing the risk of complications like endoleaks. This customization is especially important for complex cases, such as thoracoabdominal aneurysms, where precision can significantly impact outcomes. Additionally, using the Cook Zenith Platform allows for adaptability and integration with existing endovascular techniques, offering a promising advance over the one-size-fits-all approach of standard treatments.

What evidence suggests that surgeon-modified fenestrated stent grafts could be effective for complex aortic aneurysms?

Research shows that surgeon-modified fenestrated stent grafts effectively and safely treat complex aortic aneurysms. In this trial, participants will join one of two treatment arms. One arm focuses on thoracoabdominal aortic aneurysm extent I-III, while the other addresses failed EVAR and other complex aneurysm types. These grafts work well for patients who have had problems with previous stent repairs. Studies have shown that skilled surgeons can successfully use this method. The grafts help seal the aorta better, preventing further issues. This approach effectively treats both types of aneurysms: those caused by tears in the aorta and those due to wear and tear. It compares well to traditional methods. Overall, evidence suggests these grafts could be a reliable option for patients with difficult aortic conditions. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with complex aortic aneurysms or failed previous infrarenal repairs, who are at high risk for open surgery. Candidates must have certain aneurysm sizes or symptoms and suitable anatomy for the procedure. Pregnant women, those under 18, patients with allergies to device materials, uncorrectable coagulopathy, or severe kidney issues cannot participate.

Inclusion Criteria

You have an aneurysm that is larger than a specific size, has grown quickly, is causing symptoms, has ruptured, or has not responded well to previous treatment.

My blood vessels are suitable for surgery, and I have a specific type of aortic condition.

Your overall health status is classified as low, medium, or high risk according to specific assessment systems.

Exclusion Criteria

Unwilling or unable to comply with the follow-up schedule

I cannot or do not want to give consent for the trial.

I see several exclusion criteria for the medical study: - You are allergic to the materials used in the devices. - You are allergic to anticoagulation or contrast media. - You have a blood clotting problem that cannot be corrected. - Your body shape makes it hard to see your aorta using x-rays. - You had major surgery or a procedure not related to treating the planned aneurysm within the last 30 days. - You have unstable angina (chest pain). - You have an infection that could increase the risk of endovascular graft infection. - Your baseline creatinine level is higher than 2.0 mg/dL. - You have a history of certain connective tissue disorders, except if you've had a previous open surgical aortic replacement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive endovascular repair using surgeon-modified fenestrated and branched stent grafts

Acute phase

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at 30 days, 6 months, 12 months, and annually up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)

Trial Overview The trial tests surgeon-modified fenestrated stent grafts on patients with complex aortic aneurysms or prior unsuccessful endovascular repairs. It aims to assess safety and effectiveness of these custom-made devices in managing life-threatening aortic conditions.

How Is the Trial Designed?

Group I: Thoracoabdominal aortic aneurysm extent I-III Experimental Treatment 1 Intervention

Thoracoabdominal aortic aneurysm extent I-III (proximal seal can be from the left carotid artery to directly after the left subclavian artery):

Group II: Failed EVAR Experimental Treatment 1 Intervention

Failed EVAR (defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss)/juxtarenal/Pararenal/paravisceral/thoracoabdominal aortic aneurysm extent IV-V:

Who Is Running the Clinical Trial?

Jesse Manunga, MD

Lead Sponsor

Trials

1

Recruited

30+

Minneapolis Heart Institute Foundation

Collaborator

Trials

32

Recruited

15,700+

Published Research Related to This Trial

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 (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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0741521423011758

Comparative outcomes of physician-modified fenestrated ... Physician-modified fenestrated-branched endovascular aneurysm repair is technically feasible and safe in patients with post-dissection and degenerative complex ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11189729/

Early Financial Outcomes of Physician Modified Endograft ... This study compared the financial and clinical outcomes of PMEGs to the Cook Zenith-Fenestrated (ZFEN) graft and open surgical repair (OSR).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06501872?cond=%22Aortic%20Aneurysm%22&aggFilters=status:not%20rec&rank=8

Safety and Effectiveness of Physician-Modified Fenestrated ... The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8167926/

Clinical application and technical details of cook zenith ... Abstract. Purpose. To describe technical details of modifying four different Cook Zenith devices to treat complex aortic aneurysms.

5. ctv.veeva.com ctv.veeva.com/study/safety-and-effectiveness-of-surgeon-modified-stent-grafts-fortreatment-of-complex-aortic-aneurysms

Safety and Effectiveness of Surgeon-Modified Stent Grafts ... The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated ...

6. ejves.com ejves.com/article/S1078-5884(22)00241-6/fulltext

Systematic Review and Meta-analysis of Physician ... Physician modified fenestrated or branched grafts for endovascular aortic repair seem feasible and safe in the short term. However, the quality ...