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PMEGs for Aortic Aneurysm
Study Summary
This trial is testing the safety and effectiveness of physician-modified endovascular grafts for endovascular repair of complex aortic pathology in high-risk patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am willing to follow the trial's schedule for check-ups and treatments.The part of my aorta closest to my heart is the right size and doesn't have an aneurysm.I have an infection that could risk a graft infection.I have been diagnosed with a connective tissue disorder.My doctor expects me to live for at least 2 more years.I have a type B aortic dissection, had surgery for type A, or have an aortic intramural hematoma.I am allergic to blood thinners or contrast dyes and it can't be managed.I cannot have certain procedures due to poor access in my leg arteries.I am considered high-risk for open surgery due to my heart/lung health, other illnesses, and the complexity of my anatomy.My blood vessels are not suitable for a specific graft due to blockage or size.You have a problem with your aorta that cannot be fixed using a specific FDA-approved medical device.I have a complex aneurysm in my abdomen near my kidneys or chest.I have a blood clotting disorder that cannot be corrected.You have an aortic aneurysm that needs to be treated quickly with a custom-made medical device approved by the FDA.My aortic condition matches one of the study groups.The aneurysm has too much blood clot or hardening in the neck area.Your body size makes it difficult to see your aorta using x-rays, or it's too big for the equipment to handle safely.I am 21 years old or older.I have had a ruptured aneurysm.My aorta or iliac artery has a specific size and length suitable for fixation.My blood vessels in the hip or thigh area are suitable for medical device insertion.I have a type I, II, or III thoracoabdominal aortic aneurysm.
- Group 1: Expanded Selection Arm
- Group 2: Type B aortic dissection
- Group 3: Thoracoabdominal aortic aneurysm (TAAA)
- Group 4: Complex abdominal aortic aneurysm (AAA)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are individuals welcome to join this research project at the present time?
"Affirmative, the clinicaltrials.gov webpage shows that this medical trial is currently recruiting patients and requires 45 participants from 1 site. This study was first made available on March 15th 2021 and has been recently modified on July 25th 2022."
How many participants have been selected for this clinical trial?
"Affirmative, the clinicaltrial.gov database shows that this medical trial is actively recruiting individuals. It was initially posted on March 15th 2021 and its last update happened on July 25th 2022; 45 patients are needed from one centre."
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