Endovascular Graft for Aortic Aneurysm

(PMEG Trial)

Overseen by Benjamin Starnes, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Washington

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Mycotic aneurysm, Unstable angina, Connective tissue disease, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a special adjustable medical tube to fix bulging blood vessels in patients who can't have traditional surgery. The tube helps strengthen the blood vessel to prevent it from bursting. This is aimed at patients with limited treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to anticoagulation or contrast media, it must be manageable with pre-treatment.

What data supports the effectiveness of the treatment Fenestrated Endovascular Graft for Aortic Aneurysm?

Research shows that fenestrated endovascular grafts, including physician-modified versions, can effectively treat complex aortic aneurysms by reducing complications and improving outcomes. These grafts are customized to fit the patient's specific needs, which helps in managing the condition more effectively. ^{1 2 3 4 5}

Is the endovascular graft for aortic aneurysm safe for humans?

Research shows that physician-modified endovascular grafts (PMEGs) and custom-made fenestrated stent grafts have been used safely in treating complex aortic aneurysms, with studies reporting on their safety and effectiveness in various conditions, including juxtarenal and thoracoabdominal aortic aneurysms. ^{4 5 6 7 8}

How is the fenestrated endovascular graft treatment different from other treatments for aortic aneurysms?

The fenestrated endovascular graft treatment is unique because it involves customized, patient-specific devices that can be modified by physicians to fit the patient's specific anatomy, potentially reducing complications and improving outcomes for complex aortic aneurysms. This approach allows for urgent treatment and can be tailored more precisely than standard, off-the-shelf devices. ^{1 2 3 4 5}

Research Team

Benjamin Starnes, MD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for adults over 18 with juxtarenal aortic aneurysms who aren't good candidates for open surgery due to high surgical risk. They must have suitable arteries for endovascular access, be willing to follow up, and not be pregnant or in another study. Exclusions include planned major procedures within 30 days, systemic infections, unstable angina, certain connective tissue diseases, allergies to specific metals or contrast agents.

Inclusion Criteria

I am a man or a woman not currently pregnant (with a negative pregnancy test if of childbearing age).

My condition is a juxtarenal abdominal aortic aneurysm.

My aneurysm has grown by 0.5 cm in the last 6 months.

Exclusion Criteria

Patient has a history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome)

Patient has a known allergy or intolerance to stainless steel or gold

Patient has a body habitus that would inhibit X-ray visualization of the aorta

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a PMEG fenestrated graft or a company manufactured Terumo Aortic Fenestrated TREO Graft

6-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Fenestrated Endovascular Graft (Endovascular Graft)

Trial Overview The trial tests if physician modified endovascular grafts are safe and effective for treating elective, symptomatic or ruptured juxtarenal aortic aneurysms in patients unsuitable for open surgery. It focuses on those without other treatment options and involves following specific protocols before and after the procedure.

Participant Groups

Group I: PMEG Fenestrated Graft or Company Manufactured Terumo Aortic Fenestrated TREO Graft Experimental Treatment 1 Intervention

Fenestrated device with PMEG fenestrations for the bilateral renal arteries, celiac and SMA. May include all three fenestrations or only one. Company manufactured device - Terumo Aortic Fenestrated TREO Abdominal Stent Graft System fenestrated for the bilateral renal arteries, celiac and SMA. May include all three fenestrations or only one.

Fenestrated Endovascular Graft is already approved in China for the following indications:

Approved in China as PMEG for:

• Thoracoabdominal aortic aneurysms (TAAAs) in patients unsuitable for open surgical repair

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

Findings from Research

In a study of 52 patients undergoing endovascular repair for degenerative aortic arch aneurysms, both single and double-fenestrated physician-modified endovascular grafts (PMEGs) demonstrated a 100% technical success rate, indicating high efficacy in this complex procedure.

The procedure showed a low 30-day mortality rate of 2% and no patients required conversion to open surgery or experienced major complications like aortic rupture or paraplegia during an average follow-up of 18 months, highlighting the safety of PMEGs for both elective and emergency repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Homemade fenestrated physician-modified stent grafts for arch aortic degenerative aneurysms. Chastant, R., Belarbi, A., Ozdemir, BA., et al.[2022]

In a study of 50 patients undergoing total endovascular aortic arch repair using double fenestrated physician-modified endovascular grafts (PMEGs), the technical success rate was high at 94%, with only a 2% 30-day mortality rate, indicating the procedure is both safe and effective.

The results suggest that stenting of the brachiocephalic trunk may not be necessary for many patients, as it did not lead to increased endoleaks or treatment failures, and was associated with a lower risk of stroke compared to other methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double fenestrated physician-modified stent-grafts for total aortic arch repair in 50 patients. Chassin-Trubert, L., Gandet, T., Lounes, Y., 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 of 82 patients undergoing fenestrated endovascular aneurysm repair, no significant differences in overall survival or major complications were found between physician-modified endografts (PMEG) and company-manufactured devices (CMD), suggesting both are safe options for complex aortic aneurysm repair.

However, PMEGs were associated with longer operative times, increased fluoroscopy time, and a higher 1-year reintervention rate (37% for PMEG vs. 13% for CMD), indicating that while both methods are viable, PMEGs may require more postoperative management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. Dossabhoy, SS., Simons, JP., Flahive, JM., et al.[2018]

In a study of 97 patients undergoing endovascular repair for complex abdominal aortic aneurysms, physician-modified stent grafts (PMSGs) showed a higher in-hospital mortality rate (14%) compared to custom-made stent grafts (CMSGs) (4%), indicating that CMSGs may be safer for patients with complex conditions.

Despite the higher mortality in the PMSG group, both graft types had similar rates of postoperative complications and target vessel patency, suggesting that PMSGs can still be a viable option for urgent cases when CMSGs are not feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms. Sénémaud, JN., Ben Abdallah, I., de Boissieu, P., et al.[2021]

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 63 patients with aortic arch pathologies treated with single-fenestrated physician-modified endografts (PMEGs), the procedure demonstrated a 98% technical success rate and acceptable early and midterm morbidity and mortality, making it a viable option for both elective and emergency situations.

Over a median follow-up of 49 months, there were no cases of reintervention for endoleaks, stent fractures, or migrations, and no patients died from an aortic cause, indicating the long-term safety and efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zone 2 Aortic Arch Repair With Single-Fenestrated Physician-Modified Endografts, at Least 3 Years of Follow-up. Bacri, C., Ata Ozdemir, B., Hireche, K., et al.[2023]

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]

References

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

Homemade fenestrated physician-modified stent grafts for arch aortic degenerative aneurysms. [2022]

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

Double fenestrated physician-modified stent-grafts for total aortic arch repair in 50 patients. [2022]

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

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

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

Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. [2018]

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

Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms. [2021]

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

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

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

Zone 2 Aortic Arch Repair With Single-Fenestrated Physician-Modified Endografts, at Least 3 Years of Follow-up. [2023]

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

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