Modified Endografting for Aortic Aneurysm

Overseen By Caren Saunders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bjoern D. Suckow

Must not be taking: Oral antiplatelets

Disqualifiers: Connective tissue disorder, others

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

Compensation: Varies

Number of Visits: 2

Duration: Day of Surgery

80 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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions a contraindication to oral antiplatelet therapy, which might suggest some restrictions. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Physician-modified Aortic Endograft for Aortic Aneurysm?

Research shows that physician-modified endografts (a type of custom-made tube used to support weakened blood vessels) are effective in treating complex aortic aneurysms, especially in high-risk patients who cannot undergo traditional surgery. Studies have reported positive outcomes in patients with various types of aortic aneurysms, indicating that this treatment can be a safe and effective option. ^{1 2 3 4 5}

Is the modified endografting for aortic aneurysm generally safe for humans?

Studies on physician-modified endovascular grafts (PMEGs) for treating aortic aneurysms suggest they are generally safe for patients who cannot undergo open surgery. These studies focus on midterm and early results, indicating that PMEGs can be a safe option for certain patients. ^{4 6 7 8 9}

How is the treatment 'Physician-modified Aortic Endograft' unique for aortic aneurysm?

The Physician-modified Aortic Endograft is unique because it allows for customization to fit the specific needs of a patient's aortic anatomy, especially in urgent situations where standard devices are not available quickly enough. This treatment can be modified with inner branches or fenestrations (small openings) to address complex aortic aneurysms, providing a tailored approach that is not possible with off-the-shelf devices. ^{5 10 11 12 13}

Research Team

Bjoern Suckow, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for individuals with thoracoabdominal aortic aneurysms (TAAAs) or pararenal aortic aneurysms. Participants should be suitable candidates for endovascular repair, meaning their anatomy must fit the criteria for using the modified graft and they need to be able to undergo the procedure.

Inclusion Criteria

Must commit to comply with the five-year study assessment schedule of events

Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years

Patient must be able to provide informed consent

Exclusion Criteria

Known connective tissue disorder

My imaging shows issues with the arteries needed for a specific medical device.

I have a major surgery planned within 30 days of my aneurysm repair.

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)

Initial Follow-up

Participants are monitored for immediate post-surgical outcomes and complications

30 days

1 visit (in-person)

Extended Follow-up

Participants are monitored for long-term safety and effectiveness of the treatment

5 years

Annual visits (in-person)

Treatment Details

Interventions

• Physician-modified Aortic Endograft

Trial Overview The study is testing the safety and effectiveness of a custom-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft compared to traditional open surgical replacement in treating TAAAs.

Participant Groups

Group I: Main Arm 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 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?

Bjoern D. Suckow

Lead Sponsor

Trials

1

Recruited

80+

Findings from Research

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]

The study involving 26 patients with juxtarenal aortic aneurysms showed that using a physician-modified endovascular graft (PMEG) is a safe procedure, with no major adverse events and only one minor complication reported during the 30-day follow-up.

PMEG demonstrated high efficacy, achieving treatment success in 87.5% of patients, with no cases of migration, rupture, or significant endoleaks, making it a promising option for patients unsuitable for open repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts. Starnes, BW., Tatum, B.[2013]

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]

References

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

Characterizing endovascular aortic intervention outcomes for nonruptured aortic aneurysms by physician specialty. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts. [2013]

7. 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]

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

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

9. 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]

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

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

11. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Endovascular Arch Repair Using Inner Branch Stent-Graft With Transapical Access. [2021]