Endovascular Grafts for Abdominal Aortic Aneurysm

Overseen By Cali Johnson, MD, EdD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cali Johnson

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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called a physician-modified endovascular graft (PMEG) to repair juxtarenal abdominal aortic aneurysms. These aneurysms are bulges in the main blood vessel near the kidneys that could burst if untreated. The trial aims to evaluate the device's effectiveness after surgery and during follow-up visits over several years. It suits individuals with a growing or symptomatic juxtarenal abdominal aortic aneurysm who can have the device inserted through their blood vessels. As an unphased trial, this study offers a unique opportunity to contribute to medical advancements and potentially benefit from cutting-edge treatment.

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 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. One study found that PMEGs succeeded in 97.2% of procedures, meaning most surgeries proceeded as planned. Another study indicated that PMEGs have low rates of long-term issues. About four years after surgery, 7.6% of patients experienced aortic-related deaths, mostly occurring soon after the procedure. These findings suggest that PMEGs are well-tolerated and effective for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Physician Modified Endovascular Graft (PMEG) is unique because it offers a tailored approach to repairing juxtarenal abdominal aortic aneurysms, which are currently treated with standard endovascular or open surgical repair. Unlike traditional methods, the PMEG allows physicians to customize the graft during the procedure to better fit the patient's specific anatomy, potentially improving the success rate and reducing complications. Researchers are excited about this innovation as it could lead to more effective and safer aneurysm repairs, offering a personalized solution that adapts to individual patient needs.

What evidence suggests that this device is effective for juxtarenal aortic aneurysms?

Studies have shown that physician-modified endovascular grafts (PMEG) effectively treat complex abdominal aortic aneurysms. In this trial, participants will undergo a surgical procedure using the PMEG device. The procedure succeeds in most cases, with a 93.7% success rate. Overall, 82.6% of patients experience good outcomes. Long-term results are excellent, with few complications and a reduction in aneurysm size in 43% of patients. These findings suggest PMEG is a promising option for managing juxtarenal aortic aneurysms. ^{1 2 6 7 8}

Who Is on the Research Team?

Cali Johnson, MD, EdD

Principal Investigator

University of Utah

Nathan Droz, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for individuals with an abdominal aortic aneurysm near the kidneys (juxtarenal) that needs repair, either because it's causing symptoms or has ruptured. Specific eligibility criteria are not provided, but typically participants must be suitable candidates for the surgical procedure.

Inclusion Criteria

Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form

Patient must be willing to comply with all required follow-up exams

I am 18 years old or older.

Exclusion Criteria

Patient has history of an aortopathic connective tissue disease

Patient has known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment

Patient has known allergy or intolerance to specific materials

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo surgery to repair their juxtarenal aortic aneurysm using the PMEG device

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with visits at hospital discharge, 1 month, 6 months, 12 months, and annually for up to 5 years

5 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Physician Modified Endovascular Graft

Trial Overview The study is testing a specialized surgery using a physician-modified endovascular graft (PMEG) to treat juxtarenal aortic aneurysms. Participants will have surgery and then attend follow-up visits to check on their recovery and how well the PMEG works over up to five years.

How Is the Trial Designed?

Group I: Physician Modified Endograft Experimental Treatment 1 Intervention

Surgical procedure to repair the juxtarenal abdominal aortic aneurysm, during which the physician-modified endovascular graft (PMEG) device will be used.

Who Is Running the Clinical Trial?

Cali Johnson

Lead Sponsor

Citations

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

Multicenter Study on Physician-Modified Endografts for ... Physician modified endografts appear to be a safe and effective treatment option for elective, symptomatic, and ruptured complex abdominal and ...

2. 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 ...

3. 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 ...

4. 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 ...

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

Comparative outcomes of physician-modified fenestrated ... The purpose of this study was to evaluate the use of PM-F/BEVAR in patients with prior failed EVAR.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04746677

Safety and Efficacy of Endovascular Repair of Complex ... The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of ...

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

Five-year outcomes of physician-modified endografts for ... After a mean follow-up of 49 ± 38 months, there were 12 aortic-related deaths (7.6%), including nine early deaths (5.7%) from perioperative ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1078588422002416

Systematic Review and Meta-analysis of Physician ... Overall technical success was 97.2%: 98.0% for extent I – III thoraco-abdominal aortic aneurysms and 99.4% for complex abdominal and extent IV thoraco-abdominal ...