Endografts for Aortic Aneurysm

Overseen By Katie O'Donnell, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Under 18, Pregnant, Life-expectancy < 2 years, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: Immediate to 30 days

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success). Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.

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 data supports the effectiveness of the treatment Endografts for Aortic Aneurysm?

Research shows that physician-modified endografts (PMEGs) are effective in treating complex aortic aneurysms, including those in patients unfit for open surgery, and have been used successfully in urgent cases and for long-term follow-up. These endografts, which can be customized for individual patients, have shown potential to reduce complications and improve outcomes compared to standard devices. ^{1 2 3 4 5}

Is the use of physician-modified endografts generally safe for treating aortic aneurysms?

Studies show that physician-modified endografts (PMEGs) have been used safely for several years in treating complex aortic aneurysms, with follow-up data indicating positive midterm and long-term outcomes. These devices have been evaluated for safety in various conditions, including juxtarenal, abdominal, and thoracoabdominal aortic aneurysms, with results suggesting they are a viable alternative to traditional open repair. ^{2 3 4 6 7}

What makes the treatment of Physician Modified Endografts unique for aortic aneurysm?

Physician Modified Endografts (PMEGs) are unique because they are customized by doctors to fit the specific anatomy of a patient's aorta, which can be particularly beneficial for complex or irregularly shaped aneurysms. This personalized approach can offer a more precise fit compared to standard endografts, potentially improving outcomes for patients with challenging cases. ^{8 9 10 11 12}

Research Team

Sukgu Han, MD

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for adults with specific types of aortic aneurysms that are at high risk for rupture or have shown significant growth. It's aimed at those who can't be treated with FDA-approved devices, aren't part of another similar clinical trial, and have a life expectancy over two years.

Inclusion Criteria

I have symptoms from an aneurysm but am not in shock.

I have an aneurysm near a previous aortic repair site.

My doctor thinks my aneurysm could burst.

Exclusion Criteria

You are not currently taking part in another experimental medical or device study, except if it's a specific type of stent-graft study done more than 30 days before the current one.

Eligible for treatment with FDA-approved marketed device

Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo physician-modified endografting for thoracoabdominal or complex abdominal aortic aneurysms

Immediate to 30 days

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of major adverse events and treatment success

5 years

Regular visits at 30 days, 3 months, 6 months, 12 months, and annually up to 5 years

Treatment Details

Interventions

• Physician Modified Endografts

Trial Overview The study tests physician-modified fenestrated/branched endografts in repairing complex aortic aneurysms in high-risk patients. It aims to evaluate the safety and effectiveness immediately after surgery, then periodically up to five years.

Participant Groups

Group I: PMEG FEVAR Experimental Treatment 1 Intervention

The only arm of this study will be enrolled subjects who undergo physician modified endografting as a treatment of their thoracoabdominal aortic aneurysms or complex abdominal aortic aneurysms.

Physician Modified Endografts is already approved in United States, European Union, China for the following indications:

Approved in United States as Physician Modified Endografts for:

• Thoracoabdominal aortic aneurysms
• Complex abdominal aortic aneurysms

Approved in European Union as Physician Modified Endografts for:

• Thoracoabdominal aortic aneurysms
• Complex abdominal aortic aneurysms

Approved in China as Physician Modified Endografts for:

• Thoracoabdominal aortic aneurysms
• Complex abdominal aortic aneurysms

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Findings from Research

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 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]

In a study of 82 patients undergoing fenestrated endovascular aneurysm repair, no significant differences in overall survival or major complications were found between physician-modified endografts (PMEG) and company-manufactured devices (CMD), suggesting both are safe options for complex aortic aneurysm repair.

However, PMEGs were associated with longer operative times, increased fluoroscopy time, and a higher 1-year reintervention rate (37% for PMEG vs. 13% for CMD), indicating that while both methods are viable, PMEGs may require more postoperative management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. Dossabhoy, SS., Simons, JP., Flahive, JM., et al.[2018]

In a study of 63 patients with aortic arch pathologies treated with single-fenestrated physician-modified endografts (PMEGs), the procedure demonstrated a 98% technical success rate and acceptable early and midterm morbidity and mortality, making it a viable option for both elective and emergency situations.

Over a median follow-up of 49 months, there were no cases of reintervention for endoleaks, stent fractures, or migrations, and no patients died from an aortic cause, indicating the long-term safety and efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zone 2 Aortic Arch Repair With Single-Fenestrated Physician-Modified Endografts, at Least 3 Years of Follow-up. Bacri, C., Ata Ozdemir, B., Hireche, K., et al.[2023]

A physician-modified endograft (PMEG) with three inner branches was successfully used to treat a 69-year-old male with an extensive aortic arch aneurysm, demonstrating its feasibility for complex cases.

The procedure was technically successful, with the patient discharged without complications, highlighting the PMEG as a safer alternative for high-risk patients who may not tolerate traditional open surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-Modified Endograft With Triple Inner Branches for Extensive Aortic Arch Aneurysm. Zhang, Y., Shen, J., Yang, P., et al.[2022]

In a study of 126 patients treated with physician-modified fenestrated and branched endografts (PMEGs) for thoracoabdominal aortic aneurysms (TAAAs), both postdissection (PD) and degenerative (DG) TAAAs showed similar midterm outcomes, including survival and freedom from complications, over an average follow-up of 3 years.

Patients with DG-TAAAs experienced more early nonaortic complications compared to those with PD-TAAAs, highlighting a need for further research to improve outcomes in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm outcomes of physician-modified endovascular grafts for repair of postdissection and degenerative thoracoabdominal aortic aneurysms. Yang, G., Zhang, M., Zhang, Y., et al.[2023]

In a study of 156 patients undergoing fenestrated-branched endovascular aortic repair (FB-EVAR) using physician modified endografts (PMEGs), those treated for complex abdominal aortic aneurysms (CAAAs) had significantly better outcomes, including higher technical success rates and lower early mortality compared to those with thoracoabdominal aortic aneurysms (TAAAs).

After an average follow-up of nearly 4 years, the study found that sac regression (shrinkage of the aneurysm sac) was linked to improved survival rates, highlighting the importance of monitoring sac size in patients treated with FB-EVAR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year outcomes of physician-modified endografts for repair of complex abdominal and thoracoabdominal aortic aneurysms. Chait, J., Tenorio, ER., Hofer, JM., et al.[2023]

In a study involving 24 human donor corneas, the Geuder glass cannula was found to cause significantly less endothelial damage (23.5% loss) compared to the modified Jones tube (37.8% loss) and the STAAR IOL injector (37.0% loss) during Descemet membrane endothelial keratoplasty (DMEK).

The results suggest that the Geuder glass cannula may be a safer and easier option for novice users, potentially reducing the risk of endothelial damage during graft injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effect of three Descemet membrane endothelial keratoplasty injectors on endothelial damage of grafts. Shen, E., Fox, A., Johnson, B., et al.[2021]

The new EndoGlide insertion method for posterior lamellar corneal grafts in DSEK resulted in significantly less endothelial cell loss (25.76%) compared to the standard Busin glide method (47.46%), indicating a safer option for patients.

Visual outcomes and refractive changes were similar between the two methods, suggesting that while the EndoGlide is more effective in preserving endothelial cells, it does not compromise the overall visual results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study comparing EndoGlide and Busin glide insertion techniques in descemet stripping endothelial keratoplasty. Gangwani, V., Obi, A., Hollick, EJ.[2022]

In a study of 300 eyes undergoing Descemet membrane endothelial keratoplasty (DMEK), 98% achieved a best spectacle corrected visual acuity (BSCVA) of ≥20/40 and 46% reached ≥20/20 within 6 months, indicating DMEK's high efficacy for visual rehabilitation.

DMEK demonstrated a relatively low complication rate, with only 10% experiencing graft detachment and 6% developing secondary ocular hypertension, suggesting it is a safe option for treating corneal endothelial disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near complete visual recovery and refractive stability in modern corneal transplantation: Descemet membrane endothelial keratoplasty (DMEK). van Dijk, K., Ham, L., Tse, WH., et al.[2022]

In a study of 752 Descemet membrane endothelial keratoplasty (DMEK) procedures in the Netherlands, graft survival rates were 87% at 3 months and 78% at 2 years, with improved survival rates for procedures performed after 2015, indicating a learning curve in the technique.

DMEK significantly improved visual acuity in patients with Fuchs' endothelial dystrophy, with average best spectacle-corrected visual acuity improving from 0.45 logMAR at baseline to 0.08 logMAR at 2 years, alongside a manageable endothelial cell loss of 33%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Outcomes of DMEK: A Prospective Dutch registry study. Dunker, SL., Veldman, MHJ., Winkens, B., et al.[2021]

In a study comparing three techniques for preparing DMEK grafts, the Jones tube and DMEK EndoGlide methods showed similar low rates of endothelial cell loss, averaging around 11% and 12.9%, respectively, after a simulated transport period.

The use of viscoelastic material with the DMEK EndoGlide technique led to significantly higher endothelial cell loss (25.7%), indicating that this protective measure may actually harm the endothelium rather than help it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Modified Jones Tube Technique and the DMEK EndoGlide Technique With and Without Viscoelastic Material for DMEK Tissue Preparation. Christopher, KL., Terrin, S., Lohmeier, J., et al.[2023]

References

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

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

2. 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]

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

Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. [2018]

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

Zone 2 Aortic Arch Repair With Single-Fenestrated Physician-Modified Endografts, at Least 3 Years of Follow-up. [2023]

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

Physician-Modified Endograft With Triple Inner Branches for Extensive Aortic Arch Aneurysm. [2022]

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

Midterm outcomes of physician-modified endovascular grafts for repair of postdissection and degenerative thoracoabdominal aortic aneurysms. [2023]

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

Five-year outcomes of physician-modified endografts for repair of complex abdominal and thoracoabdominal aortic aneurysms. [2023]

8. India pubmed.ncbi.nlm.nih.gov

Comparing the effect of three Descemet membrane endothelial keratoplasty injectors on endothelial damage of grafts. [2021]

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

A prospective study comparing EndoGlide and Busin glide insertion techniques in descemet stripping endothelial keratoplasty. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Near complete visual recovery and refractive stability in modern corneal transplantation: Descemet membrane endothelial keratoplasty (DMEK). [2022]

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

Real-World Outcomes of DMEK: A Prospective Dutch registry study. [2021]

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

Comparison of the Modified Jones Tube Technique and the DMEK EndoGlide Technique With and Without Viscoelastic Material for DMEK Tissue Preparation. [2023]