Modified Stent Grafts for Aortic Aneurysm

Recruiting at 1 trial location

Overseen By Kate M Horiuchi, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Life expectancy < 2 years, Others

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

Compensation: Varies

Number of Visits: 30

Duration: 12 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment for specific types of aortic aneurysms, which are dangerous bulges in the aorta, the body's main artery. The treatment uses customized stent grafts (tubes placed inside the blood vessel) to repair these aneurysms, known as Physician-Modified Fenestrated and Branched Stent Grafts. Individuals at high risk due to heart or lung issues, or those with previous abdominal surgeries, might be suitable candidates. The trial divides participants into three groups to address different types of aortic aneurysms and their urgency. Participants will receive treatment with these special stent grafts to determine if they outperform current options. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those at high risk.

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 these physician-modified stent grafts are safe for treating aortic aneurysms?

Research has shown that specially modified stent grafts are generally safe for treating complex aortic aneurysms. A large study found these grafts both safe and effective, even when other treatments had failed.

Another study, involving multiple medical centers, confirmed the safety and effectiveness of these stent grafts for complex abdominal and thoracoabdominal aortic aneurysms. Consistent findings across different studies indicate that patients tolerate these grafts well.

Overall, these studies suggest that this treatment is safe and could be a good option for those with complex aneurysms. Discussing any concerns with a healthcare provider is important, but the research so far appears promising for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these physician-modified fenestrated and branched stent grafts because they offer a tailored approach to repairing aortic aneurysms. Unlike traditional stent grafts, which may not fit all types of aneurysms perfectly, this technique allows doctors to modify the grafts to suit the unique anatomy of each patient’s aneurysm. This customization could potentially lead to better outcomes, fewer complications, and a broader range of patients who can benefit from endovascular repair. The ability to treat complex aneurysms, such as those with short necks or those that are thoracoabdominal, is particularly promising and could expand the options available for patients with these challenging conditions.

What evidence suggests that physician-modified stent grafts are effective for aortic aneurysms?

Research has shown that specially modified stent grafts, like those studied in this trial, are safe and effective for treating complex aortic aneurysms. In one study, 97.2% of patients who received this treatment survived, and 97.3% did not experience issues with the graft branches after three years. Additionally, 86.9% had no leaks (unintended blood flow into the aneurysm), and 85.8% did not need further procedures. These results are promising for managing complex aneurysms, making this treatment a good option for patients with these conditions. Participants in this trial will have their aortic aneurysms repaired using investigational physician-modified grafts, tailored to their specific aneurysm type. ^{3 4 6 7 8}

Who Is on the Research Team?

Bernardo C Mendes, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for patients with specific types of aortic aneurysms, including juxtarenal, pararenal, and thoracoabdominal. Participants should require endovascular treatment but the exact eligibility criteria are not provided in the information given.

Inclusion Criteria

I am considered high risk for standard surgery.

I have had previous surgeries or treatments in my abdomen or pelvis, or a history of severe abdominal infections.

I am over 75 or have serious health issues like heart or lung disease, kidney problems, or a high ASA score.

Exclusion Criteria

My blood vessels are not suitable for certain types of stent graft surgery.

I haven't had surgery or an interventional procedure in the last 30 days.

I don't have allergies to specific materials, severe reactions to contrast dye, bleeding disorders, fungal aneurysms, ongoing infections, certain connective tissue diseases, or a body shape that limits X-ray use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular treatment of aortic aneurysms using physician-modified stent grafts

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

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

What Are the Treatments Tested in This Trial?

Interventions

• Physician-Modified Fenestrated and Branched Stent Grafts

Trial Overview The study is testing the safety and effectiveness of modified stent grafts (Cook Alpha TX2 Stent Graft, Cook Zenith TX2, Cook Zenith Fenestrated) in treating complex aortic aneurysms that may involve iliac arteries.

How Is the Trial Designed?

Group I: Subjects with urgent or emergent aneurysms Experimental Treatment 1 Intervention

Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Group II: Subjects with thoracoabdominal aortic aneurysms Experimental Treatment 1 Intervention

Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Group III: Subjects with short neck infrarenal, juxtarenal, suprarenal and extent IV TAA Experimental Treatment 1 Intervention

Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

The study reviewed over 100 cases of branched and fenestrated stent-graft repairs for complex aortic aneurysms, highlighting the technical challenges and complications associated with this endovascular approach, such as stent-graft dislocation and vessel occlusion.

Based on their experience, the authors propose several modifications to the technique that could enhance the outcomes of these complex endovascular repairs, aiming to reduce the need for secondary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pararenal and thoracoabdominal aortic aneurysm repair with fenestrated and branched endografts: lessons learned and future directions. Austermann, M., Donas, KP., Panuccio, G., et al.[2016]

In a study of 113 patients undergoing fenestrated and branched stent grafting for complex aortic diseases, intraoperative adverse events (IOAEs) occurred in 30.1% of patients, leading to significant complications in many cases.

Patients who experienced IOAEs had a higher rate of death or moderate to severe complications compared to those without IOAEs, highlighting the need for careful monitoring during these complex procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of intraoperative adverse events during branched and fenestrated aortic stent grafting on postoperative outcome. Cochennec, F., Kobeiter, H., Gohel, MS., et al.[2021]

Approximately 40% of patients with infrarenal aortic aneurysms face limitations in endovascular therapy due to anatomical constraints, highlighting the need for more adaptable treatment options.

Modified stent grafts with reinforced fenestrations or side branches may provide a promising solution for high-risk patients requiring urgent treatment for complex aneurysms, potentially allowing for immediate intervention in cases of impending or contained ruptures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urgent endovascular treatment of symptomatic or contained ruptured aneurysms with modified stent grafts. Oderich, GS., Farber, MA., Sanchez, LA.[2016]

Fenestrated and branched stent grafts have been developed to treat abdominal aortic aneurysms in patients who are not suitable for traditional endovascular repair due to unfavorable anatomy, allowing for a completely endovascular approach.

These advanced stent grafts have shown promising short-term results that are comparable to open surgery, providing a viable option for patients with complex aneurysms and limited surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated and branched stent grafts. Ricotta, JJ., Oderich, GS.[2016]

Fenestrated stent-grafts are effective for treating short-necked aneurysms, allowing for the preservation of important side branches like renal arteries, with excellent patency rates reported in experienced centers.

The report summarizes a 5-year experience with these grafts, highlighting their technical principles and the feasibility of using either covered stents or fully branched grafts, each with its own advantages and limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated and branched stent-grafting: a 5-years experience. Verhoeven, EL., Tielliu, IF., Muhs, BE., et al.[2019]

Citations

1. jvascsurg.org jvascsurg.org/article/S0741-5214(23)01590-2/fulltext

Comparative outcomes of physician-modified fenestrated ... The purpose of this study was to evaluate the use of PM-F/BEVAR in patients with prior failed EVAR.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39947307/

Result of a Multicenter Study on the Physician-Modified ... Conclusions: Fenestrated and branched endovascular aneurysm repair with PMEGs appears to be a safe and effective treatment for complex aortic aneurysms.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.068587

Multicenter Study on Physician-Modified Endografts for ... We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666250723000135

Midterm outcomes of physician-modified endovascular ... At 3 years, survival, freedom from any branch instability, and freedom from endoleak and reintervention were 97.2%, 97.3%, 86.9%, and 85.8% in the PD-TAAAs ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02989948

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

6. sciencedirect.com sciencedirect.com/science/article/pii/S0741521423015902

Comparative outcomes of physician-modified fenestrated ... Physician-modified fenestrated/branched EVAR is safe and effective treatment option for patients with complex aneurysms who have a prior failed EVAR in place.

7. 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 ...

8. jvascsurg.org jvascsurg.org/article/S0741-5214(23)01175-8/fulltext

Comparative outcomes of physician-modified fenestrated ... The aim of this study is to compare the clinical outcomes of patients who underwent PM-FBEVAR for degenerative and post-dissection cAAAs or TAAAs.