PMEGs for Aortic Aneurysm

Overseen By Theresa Bishop, 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

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.

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 data supports the effectiveness of the treatment Physician-modified Endovascular Graft (PMEG) for Aortic Aneurysm?

Research shows that PMEGs are effective for treating complex aortic aneurysms, especially in patients who cannot undergo open surgery. Studies indicate that PMEGs provide a survival benefit over other techniques like parallel grafting for certain types of aortic aneurysms. ^{1 2 3 4 5}

Is the physician-modified endovascular graft (PMEG) safe for humans?

Research shows that PMEGs have been used safely in patients with complex aortic aneurysms who are not suitable for open surgery, indicating they are generally safe for human use. ^{1 2 3 5 6}

How is the treatment PMEG different from other treatments for aortic aneurysms?

The Physician-modified Endovascular Graft (PMEG) is unique because it is customized by doctors to fit the specific needs of patients who cannot undergo open surgery for aortic aneurysms. This approach allows for a more personalized treatment compared to standard off-the-shelf devices. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

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

3. 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]

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

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

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

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

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]