PMEG for Aortic Aneurysm

Recruiting at 1 trial location

Overseen By Beth Montera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Konstantinos Dean Arnaoutakis, MD

Disqualifiers: Severe CHF, Unstable angina, Stroke, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 4 weeks

30 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 customized stent, known as a PMEG (Physician-Modified Endovascular Graft), for treating certain aortic aneurysms. Aortic aneurysms are dangerous bulges in the major artery leading from the heart, and this treatment targets those unable to undergo traditional surgery or use standard stents. The trial suits individuals with complex aortic conditions requiring a more tailored approach. Participants should have aneurysms affecting specific arteries and have exhausted other options. As an unphased trial, it offers patients a unique opportunity to access innovative treatments tailored to their specific needs.

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

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this surgeon-modified endograft is safe for treating aortic aneurysms?

Research has shown that physician-modified endografts (PMEGs) are generally safe for treating complex aortic aneurysms. Studies have found that PMEGs are correctly placed 93.7% of the time. The treatment's overall success rate is 82.6%, which is promising.

Regarding safety, PMEGs have demonstrated low rates of long-term issues. Data indicate that death rates within 30 days and one year after the procedure are about 8.3%, comparable to other treatments.

Overall, PMEGs appear to be a safe option with good results for patients requiring this type of treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about physician-modified endografts (PMEG) for treating aortic aneurysms because they offer a customized approach that standard endovascular aneurysm repair (EVAR) doesn't. Unlike traditional methods, PMEGs are modified in the operating room to fit the patient's unique anatomy, potentially leading to better outcomes. This tailored fit can be crucial for patients with complex aneurysms that are not suitable for off-the-shelf devices, giving hope for improved safety and effectiveness in these challenging cases.

What evidence suggests that PMEG is effective for aortic aneurysm?

Research shows that doctor-modified endografts (PMEGs), which participants in this trial will receive, offer a promising treatment for complex aortic aneurysms. Studies have found that the procedure succeeds as planned 93.7% of the time and effectively manages the condition in 82.6% of patients. PMEGs are safe and effective, even in challenging cases where traditional treatments fail. Long-term evidence supports their use, showing low complication rates over time. ^{1 2 3 5 6}

Who Is on the Research Team?

Konstantinos Arnaoutakis, MD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for adults over 18 with thoracoabdominal or pararenal aortic aneurysms unsuitable for traditional surgery due to health and anatomical reasons. Candidates must have specific artery conditions, adequate access for the device, and expect to live more than a year after repair. Exclusions include severe heart failure, kidney issues not on dialysis, allergies to materials used, poor body imaging conditions, pregnancy/lactation, major upcoming surgeries, participation in other trials within 30 days.

Inclusion Criteria

My surgery area is stable for treatment.

I have 5 or fewer non-aneurysmal arteries in my abdomen measuring 4-12mm.

Provision of signed and dated informed consent form

Exclusion Criteria

I do not have a bleeding disorder that can't be corrected.

Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device

I cannot walk by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive surgeon-modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Multiple visits at Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60

What Are the Treatments Tested in This Trial?

Interventions

• PMEG

Trial Overview The trial tests PMEG (surgeon modified endografts) effectiveness and safety in repairing complex aortic aneurysms when standard devices aren't suitable. It focuses on patients who can't undergo conventional open repair because of their anatomy or other health problems that make them high-risk candidates.

How Is the Trial Designed?

Group I: Physician-modified endografts Experimental Treatment 1 Intervention

For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room.

PMEG is already approved in United States, European Union for the following indications:

Approved in United States as PMEG for:

• Pararenal aortic aneurysms
• Thoracoabdominal aortic aneurysms

Approved in European Union as PMEG for:

• Juxtarenal aortic aneurysms
• Thoracoabdominal aortic aneurysms

Who Is Running the Clinical Trial?

Konstantinos Dean Arnaoutakis, MD

Lead Sponsor

Trials

1

Recruited

30+

Konstantinos Arnaoutakis

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38920026/

Long-Term Results of Physician-Modified Endografts for ... Technical success was 93.7%, and overall treatment success was 82.6%. Conclusions: PMEG can be performed with low rates of long-term morbidity ...

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

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

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480424001707

Early Financial Outcomes of Physician Modified Endograft ... This study compared the financial and clinical outcomes of PMEGs to the Cook Zenith-Fenestrated (ZFEN) graft and open surgical repair (OSR).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11379358/

Long-Term Results of Physician-Modified Endografts for the ... PMEG can be performed with low rates of long-term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(22)02321-7/fulltext

Five-year outcomes of physician-modified endografts for ... The aim of this study was to evaluate and compare the early and long-term outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) for CAAAs and ...

6. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2024/10000/long_term_results_of_physician_modified_endografts.10.aspx

Long-Term Results of Physician-Modified Endografts for the... These long-term results are excellent and verify our early and mid-term reports that endovascular repair with PMEG is safe and effective for managing patients ...