PMEGs for Aortic Aneurysm

Overseen By Jessica Kelliher, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Pregnancy, Ruptured aneurysm, Connective tissue disorders, 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: 3

Duration: During hospitalization

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for individuals with complex aortic issues, the main blood vessel from the heart. It focuses on three conditions: complex abdominal aneurysms (bulges in the lower aorta), thoracoabdominal aneurysms (bulges in the chest and belly), and aortic dissection (a tear in the aorta's wall). Individuals who face high risks or complications that prevent regular surgery might be suitable for this trial. As an unphased trial, it offers patients a unique opportunity to access innovative treatments not available through standard care.

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

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

What prior data suggests that physician-modified endovascular grafts (PMEGs) are safe for aortic aneurysm repair?

Research has shown that physician-modified endovascular grafts (PMEGs) are generally safe for treating complex aortic conditions. Studies have identified PMEGs as a good option for patients with complicated abdominal and thoracoabdominal aortic aneurysms, suitable for both planned and emergency situations.

One study examining long-term results found PMEGs to be safe and effective. Another study confirmed their efficacy in complex cases and their durability over time, indicating they can last and function effectively for years.

Overall, these findings suggest PMEGs are well-tolerated with a low rate of complications. Although once considered experimental, current evidence supports their safety for those requiring this specialized approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Physician-modified Endovascular Grafts (PMEGs) because they offer a potential solution for high-risk patients with aortic aneurysms who aren't eligible for traditional surgeries. Unlike standard treatments such as open surgical repair or off-the-shelf endografts, PMEGs are custom-modified by physicians to precisely fit the unique anatomy of each patient. This tailored approach could lead to better outcomes and fewer complications, especially for complex cases like thoracoabdominal and complex abdominal aortic aneurysms. By enabling a more personalized treatment, PMEGs could significantly expand the options available for patients who previously had limited or risky choices.

What evidence suggests that this trial's treatments could be effective for aortic aneurysm and dissection?

Research has shown that doctor-modified endovascular grafts (PMEGs) are safe and effective for treating complex aortic aneurysms. This trial will evaluate PMEGs across various treatment arms. In the arm focusing on complex abdominal aortic aneurysms, PMEGs have demonstrated good long-term results, effectively repairing the aneurysm. For thoracoabdominal aneurysms, another arm in this trial, PMEGs offer similar benefits, proving to be a reliable option. Early findings suggest these grafts work well for aortic dissections, which will be assessed in a separate arm, providing a good treatment choice for these serious conditions. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 21 with complex aortic problems like certain aneurysms or dissections, who are at high risk from traditional surgery. They should have specific measurements in their non-aneurysmal aorta and be able to undergo endovascular repair. Pregnant women, those with allergies to device materials, connective tissue disorders, or conditions preventing informed consent are excluded.

Inclusion Criteria

The part of my aorta closest to my heart is the right size and doesn't have an aneurysm.

My doctor expects me to live for at least 2 more years.

I have a type B aortic dissection, had surgery for type A, or have an aortic intramural hematoma.

Exclusion Criteria

Known sensitivities or allergies to the materials of construction of the devices

Subject is pregnant or breastfeeding

Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants are evaluated preoperatively to assess their suitability for the procedure

1 week

1 visit (in-person)

Treatment

Participants undergo endovascular repair with physician-modified endovascular grafts (PMEGs)

During hospitalization

Procedure and hospitalization

Postoperative Monitoring

Participants are monitored for perioperative mortality and major adverse events

Up to 30 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including technical success, endoleak rate, and target vessel patency

5 years

1-month, 6-months, 1-year, and annually for 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Physician-modified Endovascular Graft (PMEG)

Trial Overview

The study tests the safety and effectiveness of custom-tailored grafts (PMEGs) used in minimally invasive procedures for repairing complex aortic pathologies. Participants will be grouped based on their specific aortic condition: abdominal aneurysm, thoracoabdominal aneurysm, or dissection.

How Is the Trial Designed?

Group I: Type B aortic dissection Experimental Treatment 1 Intervention

Includes all Type B dissections

Group II: Thoracoabdominal aortic aneurysm (TAAA) Experimental Treatment 1 Intervention

Includes Type I, Type II, and Type III TAAA

Group III: Expanded Selection Arm Experimental Treatment 1 Intervention

Includes high risk subjects who do not meet inclusion criteria for Arms !-3

Group IV: Complex abdominal aortic aneurysm (AAA) Experimental Treatment 1 Intervention

Includes juxtarenal AAA, suprarenal AAA, and type IV thoracoabdominal aortic aneurysm

Physician-modified Endovascular Graft (PMEG) is already approved in United States for the following indications:

Approved in United States as PMEG for:

• Complex abdominal aortic aneurysm (AAA)
• Thoracoabdominal aortic aneurysm
• Aortic dissection

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

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 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]

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]

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 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.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.068587

Multicenter Study on Physician-Modified Endografts for ...

We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic ...

2.

pubmed.ncbi.nlm.nih.gov

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

Multicenter Study on Physician-Modified Endografts for ...

PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666250723000135

Midterm outcomes of physician-modified endovascular ...

PMEG achieved similar midterm outcomes in postdissection and degenerative TAAAs. However, patients with degenerative TAAAs were more prone to early ...

4.

jvascsurg.org

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

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

This study reviews and compares the long-term outcomes of FB-EVAR with PMEGs for complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05339061

Physician Modified Endograft For Complex Aortic ...

The goal of this IDE is to repair complex aortic aneurysms involving the visceral vessels (renal arteries, superior mesenteric artery and/or celiac artery) ...

6.

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...

While historically considered experimental, these results suggest that PMEG is a safe and durable option and should be considered for patients where off-the- ...