Endovascular Aneurysm Repair for Aortic Aneurysm

Overseen By Kathleen Groh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

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 custom-made device for high-risk patients with complex aneurysms near vital organs. The device is inserted through a minimally invasive procedure to reinforce blood vessel walls and ensure proper blood flow. It is designed for patients who cannot use standard treatments. The device has been customized for patient anatomy to treat complex aortic aneurysms.

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.

Is endovascular aneurysm repair using physician-modified endografts generally safe for humans?

Research shows that physician-modified endovascular grafts (PMEGs) have been used safely in patients with complex aortic aneurysms who are not suitable for open surgery. These studies suggest that PMEGs are a safe option for treating certain types of aortic aneurysms. ^{1 2 3 4 5}

How is the Physician Modified Endograft treatment different from other treatments for aortic aneurysms?

The Physician Modified Endograft (PMEG) is unique because it is customized by doctors to fit the specific needs of patients with complex aortic aneurysms, especially those who cannot undergo open surgery. This approach allows for a more tailored and potentially safer treatment option compared to standard endovascular or open surgical methods. ^{1 3 4 5 6}

What data supports the effectiveness of the treatment Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA), Physician Modified Endograft, PMEG?

Research shows that physician-modified endografts (PMEG) are effective for treating complex aortic aneurysms, including thoraco-abdominal and complex abdominal types, especially in patients unsuitable for open surgery. Studies indicate PMEGs offer a survival benefit over other techniques like parallel grafting for thoracoabdominal aneurysms. ^{1 4 5 6 7}

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.

Aorta with a disorganized or irregular appearance.

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

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, San Diego

Lead Sponsor

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 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]

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]

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]

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 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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Physician-modified endografts are associated with a survival benefit over parallel grafting in thoracoabdominal aneurysms. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Physician Modified Endografts for Treatment of Thoraco-Abdominal and Complex Abdominal Aortic Aneurysms. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts. [2013]

6. Italy pubmed.ncbi.nlm.nih.gov

Evaluation of physician-modified endografts for the treatment of thoraco-abdominal and pararenal aortic pathologies at a single institution. [2022]

7. United States 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. [2017]