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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral 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 data supports the effectiveness of the treatment using modified stent grafts for aortic aneurysm?

The parallel grafting technique (PGT) is highlighted as a valuable alternative for complex aortic aneurysms due to its adaptability to different anatomical challenges during surgery, suggesting that similar flexibility in modified stent grafts could enhance their effectiveness in treating aortic aneurysms. ^{1 2 3 4 5}

Is the modified stent graft for aortic aneurysm safe for humans?

The Zenith fenestrated endovascular graft (ZFEN) has been used in treating complex aortic aneurysms and is associated with lower risks of complications compared to open surgery. Studies show that patients can recover quickly, with some discharged the next day without complications, and follow-up imaging showing no issues with the graft. ^{6 7 8 9 10}

How is the Modified Stent Grafts for Aortic Aneurysm treatment different from other treatments?

The Modified Stent Grafts for Aortic Aneurysm treatment is unique because it uses customized, patient-specific fenestrated stent grafts, which are designed to fit the individual anatomy of patients with complex aortic aneurysms. This approach allows for the repair of aneurysms that are not suitable for traditional endovascular repair, potentially reducing complications and improving outcomes. ^{8 9 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

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

Prospective controlled study of rectangular titanium cage fusion compared with iliac crest autograft fusion in anterior cervical discectomy. [2019]

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

Late stent-graft migration secondary to separation of the uncovered segment from the main body of a Zenith endoluminal graft. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Parallel Graft Technique in a Complex Aortic Aneurysm: The Value of Intra-operative Flexibility from The Original Operative Plan. [2022]

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

Sagittal Reconstruction of the Atlantoaxial Lateral Mass Complex with an Intra-Articular Cage Fusion Technique for Degenerative Atlantoaxial Instability. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Modified technique for C1-2 screw-rod fixation and fusion using autogenous bicortical iliac crest graft. [2021]

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

Intermediate results of a United States multicenter trial of fenestrated endograft repair for juxtarenal abdominal aortic aneurysms. [2022]

7. 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]

8. 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]

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

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

10. 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]

11. 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]

12. Switzerland pubmed.ncbi.nlm.nih.gov

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

13. Netherlands pubmed.ncbi.nlm.nih.gov

Low-profile Zenith Alpha™ Thoracic Stent Graft Modification Using Preloaded Wires for Urgent Repair of Thoracoabdominal and Pararenal Abdominal Aortic Aneurysms. [2020]