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Endoprosthesis for Abdominal Aortic Aneurysm
Study Summary
This trial will test the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis for treating abdominal aortic aneurysms.
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 a thoracic aortic aneurysm that needs surgery.I am a man or a woman unable to have children.I have an infection that could risk a graft infection.I am scheduled for a major surgery within the next 30 days.You have a history of using drugs in a harmful way.I have a fungal or burst blood vessel bulge.My heart condition severely limits my physical activity.My blood vessel condition is not suitable for standard procedures.My abdominal aorta is enlarged, growing quickly, or causing symptoms without bursting.You are expected to live for more than 2 years.You have a body shape or medical condition that makes it difficult to see the aorta clearly.You are allergic to the materials used in the device.My leg arteries are very narrow or twisted.My body is suitable for a specific AAA stent based on artery sizes and angles.I am 21 years old or older.I have a condition like Marfan or Ehler-Danlos Syndrome.My kidney function is low, with creatinine over 2.5 mg/dL or I am on dialysis.
- Group 1: Short Neck Substudy
- Group 2: High Neck Angulation Substudy
- 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
What are the primary objectives of this experimental research?
"Over the course of one year, researchers will observe a composite of safety-related Adverse Events to determine this clinical trial's primary outcome. Secondary objectives involve assessing Migration (10 mm or more) as an indicator for efficacy, identifying Type III endoleaks in connection with effectiveness, and evaluating Stent fracture through core lab analysis for further evidence of efficacy."
How many participants are there in this experiment?
"Affirmative. Clinicaltrials.gov data indicates that this clinical trial is recruiting participants, with the original posting and subsequent editing occurring on December 19th 2017 and April 25th 2022 respectively. 190 individuals across 45 sites need to be enrolled in total."
Are there many locations in Canada currently conducting this experiment?
"This trial is available at 45 different sites including Ochsner Clinic Foundation in New Orleans, River City Clinical Research in Jacksonville and Essentia Institute of Rural Health located in Duluth."
Is there a call for volunteers at this moment to participate in the research?
"According to clinicaltrials.gov, this study is actively recruiting participants as of April 25th 2022 - a trial that was originally posted in December 19th 2017."
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