Endovascular Graft for Aortic Aneurysm

(PMEG Trial)

Overseen By Allison Larimore, MSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anticoagulants, Contrast media

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

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of endovascular graft (a tube used to support blood vessels) to treat juxtarenal aortic aneurysms (bulges in the aorta near the kidneys) without open surgery. It targets individuals who cannot undergo traditional surgery and have limited options. The trial also aims to determine if a 3-D printed model of the aorta can improve doctors' procedural planning. Individuals with a large abdominal aortic aneurysm that has recently grown or is unusually large might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to innovative research that could expand treatment options for complex aneurysms.

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 prior data suggests that these investigational devices are safe for treating aortic aneurysms?

Research has shown that fenestrated endovascular grafts (special tubes used to fix blood vessels) are generally safe for treating complex aortic aneurysms. Studies indicate that these grafts can be effective even for patients who have had a previous unsuccessful repair. Patients receiving these grafts often experience low rates of long-term health issues and procedure-related deaths, suggesting that the treatment is well-tolerated over time.

Additionally, physician-modified endografts (customized tubes made by doctors) have demonstrated effectiveness with low risk in emergency situations. These findings provide strong evidence that the investigational devices in this trial are safe for patients who need them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Fenestrated Endovascular Graft is unique because it offers a customizable approach to treating aortic aneurysms. Unlike traditional open surgery or standard endovascular grafts, this treatment allows for tailored fenestrations, or openings, that can precisely accommodate the patient's unique anatomy, particularly targeting the renal arteries, celiac, and superior mesenteric artery (SMA). Researchers are excited because this method could enhance the precision and efficacy of aneurysm repairs, potentially reducing recovery time and improving outcomes compared to conventional procedures.

What evidence suggests that these investigational devices are effective for treating aortic aneurysms?

Research has shown that special types of stents, called fenestrated endovascular grafts, offer a promising treatment for complex aortic aneurysms. In this trial, participants may receive either doctor-customized stents, known as PMEGs, or the company-manufactured Terumo Aortic Fenestrated TREO Graft. Studies have found that PMEGs can be used safely with low long-term risks. These stents are particularly beneficial for patients unable to undergo open surgery, including those with unsuccessful previous repairs. Research suggests they remain effective even in emergencies. Tailored to fit each patient's unique anatomy, these stents help improve outcomes. Overall, evidence supports their use as a safe and effective treatment for aortic aneurysms. ^{1 2 3 4 5}

Who Is on the Research Team?

Benjamin Starnes, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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).

- Patient must be willing to comply with all required follow-up exams

My condition is a juxtarenal abdominal aortic aneurysm.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Fenestrated 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.

How Is the Trial Designed?

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 United States, China for the following indications:

Approved in United States as PMEG for:

• Elective, symptomatic or ruptured juxtarenal aortic aneurysms in patients unsuitable for open surgical repair

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11379358/

Long-Term Results of Physician-Modified Endografts for the ... PMEG can be performed with low rates of long-term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0741521423015902

Comparative outcomes of physician-modified fenestrated ... Physician-modified fenestrated/branched EVAR is safe and effective treatment option for patients with complex aneurysms who have a prior failed EVAR in place.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.068587

Multicenter Study on Physician-Modified Endografts for ... Outcomes following urgent fenestrated-branched endovascular repair for pararenal and thoracoabdominal aortic aneurysms. Ann Vasc Surg. 2022 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01538056

Physician Modified Endovascular Grafts (PMEG) Significant aortic neck dilation occurs after repair of juxtarenal aneurysms with fenestrated endovascular aneurysm repair. J Vasc Surg. 2021 Oct;74(4):1090 ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(23)01175-8/fulltext

Comparative outcomes of physician-modified fenestrated ... The aim of this study is to compare the clinical outcomes of patients who underwent PM-FBEVAR for degenerative and post-dissection cAAAs or TAAAs.