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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

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

Timeline

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fenestrated procedureExperimental Treatment1 Intervention
Fenestrated device with fenestrations for bilateral renal ateries and SMA. May include all three fenestrations or only one

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.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,805 Previous Clinical Trials
1,912,475 Total Patients Enrolled
Benjamin W Starnes, MD3.33 ReviewsPrincipal Investigator - University of Washington
University of Washington

Media Library

Fenestrated Endovascular Graft (Endovascular Graft) Clinical Trial Eligibility Overview. Trial Name: NCT01538056 — N/A
Abdominal Aortic Aneurysm Research Study Groups: Fenestrated procedure
Abdominal Aortic Aneurysm Clinical Trial 2023: Fenestrated Endovascular Graft Highlights & Side Effects. Trial Name: NCT01538056 — N/A
Fenestrated Endovascular Graft (Endovascular Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01538056 — N/A
~82 spots leftby Jan 2030