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Endovascular Graft Repair for Aortic Aneurysm
Study Summary
This trial is testing a new device to treat complex aortic aneurysms and thoracoabdominal aortic aneurysms in high-risk patients. The trial will assess the safety and preliminary effectiveness of the device, as well as renal function, radiation exposure, and quality of life.
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 have not had major surgery unrelated to aneurysm treatment within the last 30 days.I have or might have a connective tissue disorder like Marfan or Ehler's Danlos Syndrome.I have or may have a connective tissue disease.You are expected to live for more than 2 years.I am under 18 years old.My aneurysm has burst causing unstable blood pressure.I have a blood clotting disorder that cannot be corrected.Your baseline creatinine level is higher than 3.0 mg/dL.Even if an aneurysm is fixed, the person is not expected to live for more than 2 years.I am currently fighting an infection.I have worsening chest pain, including new pain at rest or at night.I am willing to travel for a special heart device procedure.I am allergic to blood thinners or contrast dyes that can't be managed with medication.My body size may prevent clear x-ray images or is too large for the equipment.Your aortic segment where the device would be placed needs to be a specific size and shape, and your blood vessels need to be suitable for the device.I am 18 years old or older.My doctor thinks my aneurysm is at high risk of bursting.My blood vessels in the hip or thigh area are suitable for medical procedures.My aortic aneurysm is due to a tear in the aorta's wall.I am at high risk for complications if I undergo open surgery.My aneurysm has grown at least 0.5 cm in a year.I have internal bleeding causing unstable blood pressure.My aortic aneurysm is larger than 5.5 cm or twice the normal size.My iliac artery is not suitable for certain types of vascular surgery due to its size or condition.I have a painful aneurysm near or above my kidneys or in my chest and abdomen area.The part of the aorta near the aneurysm (called the neck) needs to be a certain size and shape to be eligible for the study.I have an infection that could risk a graft infection.My veins are not suitable for certain medical procedures without open surgery.
- Group 1: Endovascular repair
- 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
Is this investigation taking on new participants?
"Affirmative. Clinicaltrials.gov documents corroborate that this medical investigation first advertised on September 20th 2021 is actively seeking volunteers. Approximately 30 patients will be recruited from a solitary research site."
What is the maximum number of participants for this clinical trial?
"Indeed, the details posted on clinicaltrials.gov show that this trial is actively recruiting volunteers. It was first published on September 20th 2021 and has been modified as recently as September 15th 2022 with a goal of 30 participants across one site."
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