Physician-Modified Endografts for Thoracoabdominal Aneurysms

(PMEG Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Steven Maximus

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Mycotic aneurysm, Infection, Unstable angina, Active malignancy, others

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

Compensation: Varies

Number of Visits: 4

Duration: Hospitalization (up to 30 days)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating thoracoabdominal and complex aortic aneurysms, which are dangerous bulges in blood vessels near the heart and abdomen. It uses physician-modified endografts (custom-made internal supports) for patients who cannot be helped by existing options and are too risky for open surgery. The trial aims to determine if this method is both safe and effective. Individuals who have had issues with previous aneurysm repairs or cannot be treated with standard devices might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to explore innovative treatment options not yet widely available.

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. It's best to discuss your specific medications with the trial team to get a clear answer.

What prior data suggests that this endovascular device is safe for treating thoracoabdominal aneurysms?

Research has shown that custom-made endografts are generally safe for treating complex aortic aneurysms. In a recent study, no deaths occurred within the first 30 days after treatment, and the rate of major complications was low at 8%. Notably, there were no cases of stroke or spinal cord problems.

These endografts are tailored to fit each patient's body, effectively treating aneurysms without the need for open surgery. While the procedure is considered safe, monitoring for complications, such as issues with the heart, kidneys, or lungs, remains important and may require further care.

Overall, earlier studies suggest this treatment is a promising option for individuals who cannot undergo traditional surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about physician-modified endografts for thoracoabdominal aneurysms because they offer a personalized approach tailored to each patient's unique anatomy. Unlike standard endovascular aneurysm repair (EVAR) procedures that use pre-manufactured grafts, these physician-modified endografts allow for precise placement of fenestrations or branches to match the patient's arterial structure. This customization could improve the alignment and function of the graft, potentially reducing complications and improving outcomes for patients with complex aneurysms. Additionally, this technique uses a minimally invasive delivery method through the arteries in the leg, which can lead to faster recovery times compared to traditional open surgery.

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

Research has shown that doctor-modified endografts (PMEGs), which participants in this trial will receive, offer a promising treatment for complex aneurysms in the chest and abdomen. Studies have found PMEGs to be safe and effective, particularly for high-risk patients who cannot undergo open surgery. After three years, 97.2% of patients remained alive, experiencing few complications such as graft branch issues or leaks. Long-term results also indicate a low number of related deaths and a significant decrease in aneurysm size for many patients. Overall, PMEGs provide a reliable and less invasive option for managing these challenging aneurysms. ^{1 2 6 7 8}

Who Is on the Research Team?

Steven Maximus, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for high-risk patients with complex or thoracoabdominal aortic aneurysms who can't be treated with standard devices and aren't candidates for open surgery. It includes those whose previous endovascular repairs have failed.

Inclusion Criteria

Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form

Cannot be treated with a currently available non-modified approved device

I am over 18 years old.

Exclusion Criteria

Patient has a limited life expectancy of less than 2 years

Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment

Thrombus or excessive calcification within the neck of the aneurysm

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular repair using physician-modified endografts for complex aortic aneurysms

Hospitalization (up to 30 days)

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular visits at 4-8 weeks, 6 months, and annually

What Are the Treatments Tested in This Trial?

Interventions

• Physician-Modified Endografts

Trial Overview The study tests physician-modified endografts in these patients, aiming to provide a minimally invasive repair option by creating a seal above the celiac artery. The main goal is to assess the safety and effectiveness of this approach over time.

How Is the Trial Designed?

Group I: Thoracoabdominal and aortic aneurysm arm Experimental Treatment 1 Intervention

The Zenith Endovascular graft is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. The physician will be creating fenestrations or branches' locations based on the the patient's anatomy. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.

Who Is Running the Clinical Trial?

Steven Maximus

Lead Sponsor

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10122143/

Midterm outcomes of physician-modified endovascular grafts ... At 3 years, survival, freedom from any branch instability, and freedom from endoleak and reintervention were 97.2%, 97.3%, 86.9%, and 85.8% in the PD-TAAAs ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07224230

Physician-Modified Endografts for Complex Aortic ... We believe that this is the safest and most effective way to repair complex extent II thoracoabdominal aneurysms with common iliac disease. In ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0741521422023217

Five-year outcomes of physician-modified endografts for ... PMEGs were associated with excellent long-term TA-related outcomes and a low incidence of late aortic-related death. Sac regression was observed in 43% of ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11189729/

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).

7. 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 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1078588425005015

Early Outcomes from the Multicentre Standardised ... There were no deaths at 30 days. The any MAE rate was 8%, with no reported episodes of stroke, transient ischaemic attack, or spinal cord ...