Endovascular Grafts for Aortic Aneurysm

Overseen By Vicky McLeod, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Akhilesh Jain

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: Unknown

Duration: Immediate (index procedure)

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special device called a Physician-Modified Endovascular Graft to repair complex aortic aneurysms. Aortic aneurysms are bulges in the large blood vessel that carries blood from the heart, which can be dangerous if they burst. The trial aims to determine if this device can safely assist people who cannot undergo regular surgery to repair these aneurysms. It seeks participants with specific types of aneurysms, particularly those that have grown quickly or caused symptoms. Candidates should have a juxtarenal abdominal aortic aneurysm, located near the kidneys, with no other treatment options available.

As an unphased trial, it provides a unique opportunity for patients to access innovative treatment options not yet widely available.

Will I have to stop taking my current medications?

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 endovascular graft is safe for treating aortic aneurysms?

Research has shown that Physician-Modified Endovascular Grafts (PMEGs) are generally safe for treating complex aortic aneurysms. One study reported a 93.7% success rate for PMEGs, indicating the procedure worked as planned for most patients. The overall success rate was 82.6%, suggesting that most people benefited from the treatment.

Long-term follow-up data revealed low rates of complications after treatment. Over five years, there were 12 deaths related to the aorta among many patients, with nine occurring shortly after surgery. This suggests that while the treatment is generally safe, risks exist, particularly during or immediately after the procedure. Overall, PMEGs are considered a safe option for those with no other treatment choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Physician Modified Aortic Endograft is unique because it offers a tailored approach to treating aortic aneurysms, a condition where the artery wall balloons and risks rupturing. Unlike traditional endografts, which are pre-manufactured and may not fit all patients perfectly, this treatment allows customization to better suit individual patient anatomy. This personalized fit aims to improve the seal and stability of the graft, potentially reducing complications and improving outcomes. Researchers are excited because this approach could offer a safer, more effective alternative for patients who might not benefit from standard endografts.

What evidence suggests that the Physician Modified Aortic Endograft is effective for treating complex aortic aneurysms?

Studies have shown that Physician-Modified Endovascular Grafts (PMEGs), which participants in this trial will receive, provide a safe and effective treatment for complex aortic aneurysms. In one study, the procedure succeeded in 93.7% of cases, meaning it went as planned. Overall, 82.6% of patients experienced good outcomes, indicating that most benefited from the treatment. Long-term research suggests these grafts have a low rate of complications over time, including a low risk of aneurysm rupture after five years. This makes PMEGs a promising option for high-risk patients who cannot undergo traditional surgery. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for high-risk patients with complex aortic aneurysms who can't undergo open surgery and lack other FDA-approved treatment options. Eligible participants must have signed consent, be at risk of rupture or symptomatic, have accessible arteries for the procedure, and meet specific aneurysm size criteria.

Inclusion Criteria

I have symptoms from an aneurysm.

My aneurysm is at high risk of bursting.

I have had a ruptured aneurysm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms

Immediate (index procedure)

Initial Follow-up

Participants are monitored for major adverse events and treatment success at 30 days post-procedure

4 weeks

Extended Follow-up

Participants are monitored for safety and effectiveness at 6 months, 12 months, and annually up to 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Physician Modified Aortic Endograft

Trial Overview The trial tests Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in patients unsuitable for open surgery. It aims to provide alternative treatments for those without approved options and suitable anatomy.

How Is the Trial Designed?

Group I: Treatment arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Akhilesh Jain

Lead Sponsor

Trials

1

Recruited

20+

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/pii/S1078588425005015

Early Outcomes from the Multicentre Standardised ... Five-year outcomes of physician-modified endografts for repair of complex abdominal and thoracoabdominal aortic aneurysms. J Vasc Surg, 77 ...

4. 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 ...

5. 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 ...