300 Participants Needed

Endovascular Graft for Aortic Aneurysm

(PMEG Trial)

AL
Overseen ByAllison Larimore, MSN, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.12678

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.12678

Who Is on the Research Team?

BW

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).
My condition is a juxtarenal abdominal aortic aneurysm.
My aneurysm has grown by 0.5 cm in the last 6 months.
See 11 more

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
See 7 more

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?
1Treatment groups
Experimental Treatment
Group I: PMEG Fenestrated Graft or Company Manufactured Terumo Aortic Fenestrated TREO GraftExperimental Treatment1 Intervention

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

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Approved in United States as PMEG for:
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Approved in China as PMEG for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Published Research Related to This Trial

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.
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.
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.
Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies.Torrealba, J., Panuccio, G., KΓΆlbel, T., et al.[2022]

Citations

Homemade fenestrated physician-modified stent grafts for arch aortic degenerative aneurysms. [2022]
Double fenestrated physician-modified stent-grafts for total aortic arch repair in 50 patients. [2022]
Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies. [2022]
Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. [2018]
Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms. [2021]
Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts. [2013]
Zone 2 Aortic Arch Repair With Single-Fenestrated Physician-Modified Endografts, at Least 3 Years of Follow-up. [2023]
Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. [2022]
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