Endovascular Aneurysm Repair for Aortic Aneurysm

Overseen By Kathleen Groh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Mycotic aneurysm, Ruptured aneurysm, Infection, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Procedural

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to repair aortic aneurysms, which are dangerous bulges in the body's main artery. The treatment uses a specially modified endograft, a supportive tube placed inside the artery, to address complex aneurysms near important arteries. Known as Physician Modified Endograft, this approach aims to determine its safety and effectiveness for individuals who cannot use standard devices and face high risks with open surgery. It suits those with large or rapidly growing aortic aneurysms who have had previous heart issues or surgeries. Researchers will monitor participants for five years to ensure the treatment's lasting success. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those with limited alternatives.

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 endovascular treatment is safe for complex aortic aneurysms?

Research has shown that physician-modified endografts are generally safe for treating complex aortic aneurysms. One study found that these endografts were successfully placed in about 94% of cases, indicating the procedure went as planned most of the time. Overall, about 83% of patients benefited from the treatment over time.

Regarding safety, around 25% of patients experienced major complications within 30 days after the procedure. This includes serious issues, but it's important to remember that these patients are already at higher risk. The death rate within 30 days was 5.8%, which can vary based on the type of aneurysm treated.

These findings suggest that while there are risks, physician-modified endografts can be a viable option for those with complex aneurysms who may not have other treatment choices. It's always best to discuss the risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for aortic aneurysms, which often involves standard endografts or open surgery, the Physician-Modified Endograft offers a personalized approach. This treatment is unique because it uses a fenestrated and branched technique, allowing it to fit the specific anatomy of complex aneurysms. Researchers are excited about this treatment because it could potentially offer a safer and more effective solution for patients with complex aortic aneurysms, reducing the risk of complications and improving overall outcomes.

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

Studies have shown that customized stents, known as physician-modified endografts (PMEGs), are safe and effective for treating complex bulges in the aorta, the main artery in the body. This trial will evaluate the safety and effectiveness of PMEGs for patients with complex, juxtarenal, pararenal, or thoracoabdominal abdominal aortic aneurysms. These stents are particularly useful for challenging cases near critical arteries, such as those supplying the kidneys. Research indicates that PMEGs perform well for various types of aortic bulges, whether planned, symptomatic, or ruptured. Early and mid-term results have been positive, demonstrating that this treatment can effectively manage these challenging cases. While researchers continue to collect long-term data, initial findings are promising for those with complex aortic issues. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for high-risk patients over 18 with complex aortic aneurysms who can't use FDA-approved endografts but have suitable anatomy for a modified version. They must not be pregnant, have good vascular access, and agree to long-term follow-up. Excluded are those with infections, allergies to device materials, other serious health issues or conditions affecting the study participation.

Inclusion Criteria

My lower artery near the hip is long enough for a safe procedure.

I have a complex aneurysm in my upper abdomen or chest.

I am a man or a woman not currently pregnant (if capable of bearing children, I have a negative pregnancy test).

Exclusion Criteria

My doctor expects I have less than 2 years to live due to my cancer.

You have a known severe allergic reaction to blood thinners or contrast dye that cannot be treated before the study.

Aorta with a disorganized or irregular appearance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Staged Procedure

A staged approach may be used to minimize risks associated with a single extensive repair, including ischemic conditioning and microembolization.

2-4 weeks prior to PMEG implantation

Treatment

Participants undergo PMEG implantation for complex aortic aneurysm repair using physician-modified endografts.

Procedural

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up at one month, six months, one year, and yearly thereafter.

5 years

Follow-up visits at 1 month, 6 months, 1 year, and annually

What Are the Treatments Tested in This Trial?

Interventions

• Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA)
• Physician Modified Endograft

Trial Overview

The trial tests a physician-modified endograft on patients with complex aortic aneurysms. It aims to cover renal arteries and others in cases where standard options aren't viable. The study will enroll 40 subjects at one site over two years and follow them for five years, assessing safety within the first month and effectiveness after one year.

How Is the Trial Designed?

Group I: Physician-Modified Endograft Experimental Treatment 1 Intervention

This is a single arm study used to evaluate the safety and effectiveness of fenestrated and branched techniques for the treatment of patients with a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysms (Extent I-V).

Physician Modified Endograft is already approved in United States for the following indications:

Approved in United States as Physician Modified Endograft for:

• Complex aortic aneurysms
• Pararenal aortic aneurysms
• Juxtarenal aortic aneurysms
• Thoracoabdominal aortic aneurysms

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

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 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]

In a study of 59 high-risk patients with pararenal and thoraco-abdominal aortic aneurysms, physician-modified endografts (PMEGs) achieved a high technical success rate of 96.6% and a 30-day mortality rate of only 5.1%, indicating their safety and efficacy as an alternative to open surgery.

During an average follow-up of 18.8 months, PMEGs demonstrated excellent primary branch patency (97.2%) and a high rate of aneurysm thrombosis (89.6%), with an overall survival rate of 94.9% at 6 months, suggesting promising long-term outcomes for patients unsuitable for conventional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of physician-modified endografts for the treatment of thoraco-abdominal and pararenal aortic pathologies at a single institution. Yang, G., Zhao, J., Zhang, L., 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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38989565/

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.

sciencedirect.com

sciencedirect.com/science/article/pii/S0741521422023217

Five-year outcomes of physician-modified endografts for ...

There is paucity of data on the durability of physician modified endografts (PMEGs) for complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05339061

Physician Modified Endograft For Complex Aortic ...

This is a single arm study used to evaluate the safety and effectiveness of fenestrated and branched techniques for the treatment of patients with a complex, ...

4.

jvascsurg.org

jvascsurg.org/article/S0741-5214(22)00755-8/fulltext

Clinical Outcomes of Physician-Modified Endograft for ...

Our multicenter experience has demonstrated PMEGs to be safe and effective and associated with satisfactory early and mid-term outcomes for complex aneurysmal ...

5.

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 ...

6.

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 ...

7.

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 ...

8.

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 ...