Endovascular Grafts for Aortic Aneurysm

Overseen By Erin Daley, MPH, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baystate Medical Center

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Infection, Unstable angina, Connective tissue disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: Periprocedural

15 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 near the kidney arteries. An aortic aneurysm is a bulge in the main abdominal blood vessel, and if it bursts, it can be life-threatening. The treatment uses a physician-modified endovascular graft (a tube-like device) to support weakened vessel walls and maintain blood flow to vital arteries. The trial seeks individuals with abdominal aortic aneurysms near their kidneys, especially those with symptoms or aneurysms at risk of bursting. Participants will undergo regular check-ups for five years to assess the treatment's effectiveness. As an unphased trial, this study offers a unique chance to contribute to groundbreaking research that could lead to new treatment options.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this device is safe for treating juxtarenal aortic aneurysms?

Research has shown that physician-modified endovascular grafts (PMEGs) are generally safe for treating complex aortic aneurysms. In one study, the procedure succeeded 98% of the time, with grafts placed correctly in most cases. Additionally, 98% of patients did not die from aneurysm-related causes, indicating strong safety results.

Another study found PMEGs to be a safe and effective option for various types of aortic aneurysms, including symptomatic or ruptured ones. Although some complications occurred, they were relatively low, with only 13% of cases experiencing issues. Most issues related to the procedure points rather than the grafts themselves.

Overall, these grafts are considered a promising option for people with complex aneurysms, especially when standard treatments might not be suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Physician Modified Endovascular Grafts are unique because they allow for customization during the procedure, which can better accommodate the complex anatomy of juxtarenal aortic aneurysms. Unlike standard endovascular aneurysm repair (EVAR), which uses pre-manufactured grafts, this approach enables physicians to modify the grafts on-the-spot to ensure a more precise fit and seal. Researchers are excited about this treatment because it could improve outcomes by reducing the risk of complications and increasing the durability of the repair, potentially offering a significant advantage over traditional methods.

What evidence suggests that this physician-modified endovascular graft is effective for treating aortic aneurysms?

Research shows that physician-modified endovascular grafts (PMEGs), which participants in this trial will receive, offer a promising treatment for complex aortic aneurysms. Studies have found that PMEGs succeed in 93.7% of cases and achieve overall treatment success in 82.6% of patients. These grafts are custom-made to fit each patient's unique anatomy, supporting the weakened part of the aorta. Long-term evidence suggests that PMEGs remain effective and safe, with low rates of aneurysm rupture and complications even five years post-treatment. This reliability makes PMEGs a strong option for managing complex aneurysms, particularly in challenging areas near the kidney arteries. ^{1 2 5 6 7}

Who Is on the Research Team?

Hazel Marecki, MD

Principal Investigator

Baystate Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with an abdominal aortic aneurysm near the kidney arteries, which poses high risks if it ruptures. Candidates must be suitable for endovascular surgery and willing to undergo follow-up studies like labs and imaging for up to 5 years after the procedure.

Inclusion Criteria

I am a man or a woman not currently pregnant.

I am 18 years old or older.

My iliac or femoral arteries are suitable for endovascular procedures.

Exclusion Criteria

Patient has history of aortopathic connective tissue disease

Patient has conditions precluding treatment or evaluation

Patient currently participating in another investigational trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo physician modified endovascular grafting of their juxtarenal aortic aneurysm

Periprocedural

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with labs, CT imaging, XRays, and ultrasounds

5 years

1 month, 6 months, 12 months, and annually

What Are the Treatments Tested in This Trial?

Interventions

• Physician Modified Endovascular Grafts

Trial Overview The study tests a custom-modified endovascular graft designed to repair juxtarenal aortic aneurysms without blocking blood flow to essential arteries. The graft's performance post-surgery and over time will be evaluated through regular medical check-ups.

How Is the Trial Designed?

Group I: Physician Modified Endograft Group Experimental Treatment 1 Intervention

Patients in this arm will undergo physician modified endovascular grafting of their juxtarenal aortic aneurysm

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Recruited

44,500+

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. 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 ...

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

Five-year outcomes of physician-modified endografts for ... PMEGs offer an effective and durable option for patients with CAAAs and TAAAs, which is reflected by the low rate of aneurysm rupture at 5 years ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0741521423015902

Comparative outcomes of physician-modified fenestrated ... Physician-modified fenestrated/branched EVAR is safe and effective treatment option for patients with complex aneurysms who have a prior failed EVAR in place.

6. jvascsurg.org jvascsurg.org/article/S0741-5214(12)00278-9/fulltext

Physician-modified endovascular grafts for the treatment of ... Technical success rate was 98%, and freedom from aneurysm-related death was 98%. There were six complications (13%). Three (6%) were access related, and three ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01538056

Physician Modified Endovascular Grafts (PMEG) 15,000 Americans die suddenly each year from rupture of an aneurysm in the aorta,which is the ninth leading cause of death in men over age 55. Aortic aneurysms ...