Modified Aortic Endograft for Aortic Aneurysm

Overseen By Allison J Hawke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Oral antiplatelets

Disqualifiers: Connective tissue disorder, Pregnancy, others

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

Compensation: Varies

Number of Visits: 31

Duration: Day of Surgery

38 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a contraindication to oral antiplatelet therapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment Physician-modified aortic endograft for aortic aneurysm?

Research shows that physician-modified endografts have been effective in treating complex aortic aneurysms, especially in high-risk patients who cannot undergo traditional surgery. Studies report positive outcomes in managing thoraco-abdominal and abdominal aortic aneurysms, indicating that this treatment can be a safe and effective option. ^{1 2 3 4 5}

Is the modified aortic endograft generally safe for humans?

Studies have shown that physician-modified endografts, used for treating various types of aortic aneurysms, are generally safe for high-risk patients, although there can be some adverse events during the procedure. ^{1 6 7 8 9}

How is the physician-modified aortic endograft treatment different from other treatments for aortic aneurysm?

The physician-modified aortic endograft is unique because it allows doctors to customize the graft (a tube used to support the artery) to fit the specific needs of a patient's aortic aneurysm, especially in complex cases. This personalized approach can be more effective than standard, off-the-shelf devices, particularly for challenging aneurysms that involve multiple parts of the aorta. ^{4 10 11 12 13}

Research Team

David P. Kuwayama, M.D., M.P.A.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for men and women over 50 with thoracoabdominal aortic aneurysms who are high-risk candidates for open surgery and not suitable for FDA-approved endovascular grafts. Participants must be able to follow a five-year study plan, have life expectancy over two years, and meet size criteria for surgical repair.

Inclusion Criteria

The doctor thinks you are at high risk for a specific type of surgery.

I have an aortic aneurysm that does not extend beyond my left subclavian artery.

My aneurysm is large enough to require surgery.

Exclusion Criteria

I have unstable chest pain.

You have a known condition that affects your connective tissues.

The area where the device will be placed is too short and may not provide a secure fit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular treatment using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft

Day of Surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments for major adverse events and treatment success

5 years

Regular visits at 30, 183 days; 1, 2, 3, 4, and 5 years

Treatment Details

Interventions

• Physician-modified aortic endograft

Trial Overview The trial tests the safety and effectiveness of a modified Cook Zenith Alpha Thoracic Endovascular Graft in treating thoracoabdominal aortic aneurysms. It aims to show that this approach is as good or better than traditional open surgical replacement.

Participant Groups

Group I: Main Arm - Physician-modified fenestrated endovascular graft Experimental Treatment 1 Intervention

Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.

Group II: Expanded Access Arm - Physician-modified fenestrated endovascular graft. Experimental Treatment 1 Intervention

Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal, thoracic, or abdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair in an expanded use population.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

David P. Kuwayama

Lead Sponsor

Trials

1

Recruited

40+

Findings from Research

Physician modified endografts (PMEG) for treating thoraco-abdominal and complex abdominal aortic aneurysms showed a high technical success rate of 97.2%, indicating that this method is effective for endovascular aortic repair.

Major adverse events occurred in 15.5% of patients within 30 days, with a higher rate in urgent cases (24.6%) compared to elective cases (11.6%), suggesting that while PMEGs are generally safe, outcomes may vary based on the urgency of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Physician Modified Endografts for Treatment of Thoraco-Abdominal and Complex Abdominal Aortic Aneurysms. Gouveia E Melo, R., Fernández Prendes, C., Caldeira, D., et al.[2022]

In a study of 59 high-risk patients with pararenal and thoraco-abdominal aortic aneurysms, physician-modified endografts (PMEGs) achieved a high technical success rate of 96.6% and a 30-day mortality rate of only 5.1%, indicating their safety and efficacy as an alternative to open surgery.

During an average follow-up of 18.8 months, PMEGs demonstrated excellent primary branch patency (97.2%) and a high rate of aneurysm thrombosis (89.6%), with an overall survival rate of 94.9% at 6 months, suggesting promising long-term outcomes for patients unsuitable for conventional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of physician-modified endografts for the treatment of thoraco-abdominal and pararenal aortic pathologies at a single institution. Yang, G., Zhao, J., Zhang, L., et al.[2022]

A physician-modified endovascular graft (PMEG) demonstrated a high technical success rate of 98% in treating juxtarenal aortic aneurysms in 47 patients, many of whom were considered unsuitable for open surgery due to their health status.

The procedure showed a low in-hospital and 30-day mortality rate of 2%, with a freedom from aneurysm-related death also at 98%, indicating that PMEG is a safe and effective treatment option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. Starnes, BW.[2022]

In a study involving 64 patients with juxtarenal aortic aneurysms, the use of physician-modified endovascular grafts (PMEGs) showed a high treatment success rate of 94.1% at 12 months, indicating their efficacy for patients unfit for open surgery.

The safety profile was also favorable, with a 30-day major adverse event rate of 11.9% and a mortality rate of 5.1%, suggesting that PMEGs are a viable option for high-risk patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms. Starnes, BW., Heneghan, RE., Tatum, B.[2017]

The use of physician-modified endografts (PMEGs) with inner branches or fenestrations is effective for urgent treatment of complex aortic aneurysms, as demonstrated in two successful cases involving a 6.8 cm juxtarenal aneurysm and a contained rupture of the thoracoabdominal aorta.

Both procedures resulted in complete exclusion of the aneurysms and had uneventful postoperative recoveries, indicating that PMEGs can be a safe and viable option for managing complex aortic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies. Torrealba, J., Panuccio, G., Kölbel, T., et al.[2022]

In a study of 813 patients with thoracoabdominal aortic aneurysms (TAAAs), those who underwent repair with physician-modified endografts (PMEG) showed improved 1-year survival rates compared to those who had parallel grafting (PG), particularly in TAAA I-III repairs (85% vs 74%).

PMEG repairs also significantly reduced the occurrence of type Ia endoleaks, especially in TAAA IV cases (1.2% for PMEG vs 21.6% for PG), and were associated with lower rates of postoperative complications, indicating a safer and more effective approach for complex aneurysm repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-modified endografts are associated with a survival benefit over parallel grafting in thoracoabdominal aneurysms. Smith, JA., Sarode, AL., Stern, JR., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Midterm Results of Physician-Modified Stent Grafts for Thoracoabdominal and Complex Abdominal Aortic Aneurysms Repair. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Physician Modified Endografts for Treatment of Thoraco-Abdominal and Complex Abdominal Aortic Aneurysms. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Evaluation of physician-modified endografts for the treatment of thoraco-abdominal and pararenal aortic pathologies at a single institution. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Endovascular Repair of Postdissection Aortic Aneurysms Using Physician-Modified Endografts. [2022]

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

Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. [2022]

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

Lifeline Registry: collaborative evaluation of endovascular aneurysm repair. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Early Results of Physician Modified Fenestrated Stent Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms. [2015]

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

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms. [2022]

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

Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms. [2017]

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

Endovascular treatment of thoracoabdominal aortic aneurysm using physician-modified endografts. [2016]

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

Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies. [2022]

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

Physician-modified endografts are associated with a survival benefit over parallel grafting in thoracoabdominal aneurysms. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Midterm outcomes of fenestrated TEVAR using physician-modified endovascular grafts for zone 2. [2022]