What side effects are associated with this type of intervention?

Endovascular repair of Abdominal Aortic Aneurysm (AAA), including treatments like Physician Modified Endovascular Grafts, commonly presents side effects such as endoleak, device migration, graft infolding or collapse, and ischemia to organs or limbs. Other potential complications include spinal cord ischemia, stroke, and access site issues like bleeding or infection. Regular postoperative monitoring and imaging are essential to manage these risks.

What prior FDA approvals exist?

The FDA has approved several endovascular devices for the treatment of Abdominal Aortic Aneurysm (AAA), which include endovascular stent-grafts. These devices, such as the Gore Excluder, Medtronic Endurant, and Cook Zenith, are designed to reinforce the weakened section of the aorta and prevent rupture. Endovascular aneurysm repair (EVAR) is a minimally invasive procedure that involves placing these stent-grafts within the aneurysm through small incisions in the groin. This method is similar to the Physician Modified Endovascular Grafts being studied, which aim to provide a safe and effective alternative for patients unsuitable for open surgical repair.

What other types of research exist?

Promising novel alternatives to Physician Modified Endovascular Grafts (PMEGs) for Abdominal Aortic Aneurysm (AAA) patients in 2024 include: 1) Custom-made endografts tailored to individual patient anatomy, 2) Branched and fenestrated endografts designed for complex aneurysms, 3) Drug-eluting stent grafts that reduce the risk of restenosis, and 4) Advanced imaging and navigation systems that enhance precision during endovascular procedures. These innovations aim to improve outcomes and expand treatment options for patients unsuitable for traditional open surgical repair.

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Endovascular Graft

Endovascular Graft for Aortic Aneurysm (PMEG Trial)

N/A

Recruiting

Led By Benjamin W Starnes, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Aneurysm has increased in size by 0.5 cm in the last 6 months

- Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft

Must not have

Patient has a mycotic aneurysm or has an active systemic infection

Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not explicitly listed here, typical risks of endovascular graft procedures can include bleeding at the access site, infection, blood clots around the graft area leading to limb ischemia (reduced blood flow), misplacement of the device causing inadequate aneurysm sealing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My iliac or femoral arteries are suitable for endovascular access.

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My aorta near my kidneys is suitable for treatment.

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I am older than 18 years.

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My abdominal aortic aneurysm is larger than 5.5 cm.

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My lower abdomen artery size is between 8 and 20 mm and not bulging.

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My iliac artery is long enough for a safe procedure and will keep at least one hypogastric artery open.

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My aorta's curve near the kidneys is less than 60 degrees.

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My aorta's upper part is the right size for surgery, not too wide or narrow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a fungal aneurysm or a current body-wide infection.

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I have worsening chest pain, including at rest or at night.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and efficacy

Secondary study objectives

Effectiveness

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PMEG Fenestrated Graft or Company Manufactured Terumo Aortic Fenestrated TREO GraftExperimental Treatment1 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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endovascular repair of Abdominal Aortic Aneurysm (AAA) involves the insertion of a stent-graft through the femoral artery to reinforce the weakened section of the aorta. The stent-graft, once positioned, expands to fit the aorta's diameter, creating a new path for blood flow and reducing pressure on the aneurysm wall. This minimally invasive approach is particularly beneficial for patients who are unsuitable for open surgical repair due to comorbidities or the aneurysm's location. The use of physician-modified endovascular grafts allows for customization to fit unique anatomical challenges, enhancing the procedure's effectiveness and safety. This matters for AAA patients as it offers a less invasive option with potentially lower perioperative risks and quicker recovery times compared to traditional open surgery.