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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating aortic aneurysms, which are dangerous bulges in a major blood vessel. The study uses special stent grafts, known as Physician Modified Endografts, which doctors modify for each patient to assess their safety and effectiveness over time. Researchers also aim to understand how a patient's frailty (physical weakness) affects recovery and overall outcomes. People with certain types of aortic aneurysms, such as those growing quickly or causing symptoms, might be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could lead to new treatment options.

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 this device is safe for treating aortic aneurysms?

Research has shown that doctor-modified endografts (PMEGs) are generally safe for treating complex aortic aneurysms. Studies have found that patients accept these endografts well, and they have been used successfully in various situations, including planned procedures and emergencies, such as when an aneurysm causes symptoms or bursts.

Data from several studies indicate that PMEGs are a safe option for patients. Reports of significant increases in major complications are uncommon, suggesting these treatments manage risks effectively. While these results are encouraging, each patient's experience may vary, so discussing specific concerns with a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional open surgery or standard endovascular repair for aortic aneurysms, physician modified endografts (PMEGs) offer a customized approach to treatment. Researchers are excited about PMEGs because they allow doctors to tailor the grafts right in the operating room, accommodating unique patient anatomy and complex aneurysms that are otherwise difficult to treat. This method provides a minimally invasive option, potentially reducing recovery time and improving outcomes for patients with thoracoabdominal or complex abdominal aortic aneurysms.

What evidence suggests that physician modified endografts are effective for aortic aneurysms?

Research has shown that doctor-modified endografts (PMEGs) effectively treat complex aortic aneurysms in the abdomen and chest. Studies have found them safe and effective for both planned procedures and symptomatic or ruptured aneurysms. In this trial, participants will receive treatment with these specially adjusted endografts, which doctors modify to fit each patient's body, helping to seal the aneurysm and prevent rupture. Early results suggest that PMEGs provide good outcomes and serve as a dependable option for patients at high risk for traditional surgery. This method aims to enhance treatment success while reducing major complications. ^{1 2 3 4 6}

Who Is on the Research Team?

Sukgu Han, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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 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 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 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]

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 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]

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 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]

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]

Citations

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

Multicenter Study on Physician-Modified Endografts for ... Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38989565/

Multicenter Study on Physician-Modified Endografts for ... PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0890509625006892

Historical evolution of physician-modified endografts ... By the 2020s, many centers undertaking complex aortic aneurysm repair had supplanted PMEGs with fenestrated and branched CMDs; yet, the role of ...

4. 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39064014/

Physician-Modified Endografts for Repair of Complex ... Physicians have proposed modifying standard endografts by manually creating graft fenestrations. This allows for effective aneurysm exclusion and satisfactory ...

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

Comparative outcomes of physician-modified fenestrated ... Take Home Message: Physician-modified fenestrated/branched EVAR is safe and effective treatment option for patients with complex aneurysms who ...