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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
PMEG Trial Summary
This trial is testing a new type of surgery for people with a certain kind of ruptured aortic aneurysm. The hope is that it will be a safe and effective option for people who can't have traditional surgery.
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.Check my eligibility
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.See study design
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.
PMEG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My aneurysm has grown by 0.5 cm in the last 6 months.
Select...
My iliac or femoral arteries are suitable for endovascular access.
Select...
My aorta near my kidneys is suitable for treatment.
Select...
I am older than 18 years.
Select...
My abdominal aortic aneurysm is larger than 5.5 cm.
Select...
My lower abdomen artery size is between 8 and 20 mm and not bulging.
Select...
My iliac artery is long enough for a safe procedure and will keep at least one hypogastric artery open.
Select...
My aorta's curve near the kidneys is less than 60 degrees.
Select...
My aorta's upper part is the right size for surgery, not too wide or narrow.
PMEG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and efficacy
Secondary outcome measures
Effectiveness
PMEG 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
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,638 Total Patients Enrolled
Benjamin W Starnes, MD3.33 ReviewsPrincipal Investigator - University of Washington
University of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My iliac or femoral arteries are suitable for endovascular access.My aorta near my kidneys is suitable for treatment.I have a fungal aneurysm or a current body-wide infection.I have worsening chest pain, including at rest or at night.I am older than 18 years.My abdominal aortic aneurysm is larger than 5.5 cm.I have a major surgery planned around the time of my AAA repair.My lower abdomen artery size is between 8 and 20 mm and not bulging.My iliac artery is long enough for a safe procedure and will keep at least one hypogastric artery open.My aorta's curve near the kidneys is less than 60 degrees.My aorta's upper part is the right size for surgery, not too wide or narrow.
Research Study Groups:
This trial has the following groups:- Group 1: Fenestrated procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are you testing this medication on?
"That is correct. The online clinicaltrial database has updated information that this study is still looking for more participants. The first posting was on March 1st, 2011 and the most recent update was on May 19th, 2022. They are enrolling 300 individuals at a single site."
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