Endoprosthesis for Abdominal Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

+50 other locations

Overseen byRobert Rhee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: W.L.Gore & Associates

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

Eligibility Criteria

This trial is for adults over 21 with abdominal aortic aneurysms (AAA) that are large, growing quickly, or causing symptoms. Participants must have a life expectancy over 2 years and suitable anatomy for the device implant. Exclusions include those with certain medical conditions like connective tissue disease, severe kidney issues, or allergies to device materials.

Inclusion Criteria

I am a man or a woman unable to have children.

An Informed Consent Form (ICF) signed by Subject

My abdominal aorta is enlarged, growing quickly, or causing symptoms without bursting.

+4 more

Exclusion Criteria

I have a thoracic aortic aneurysm that needs surgery.

I have an infection that could risk a graft infection.

I am scheduled for a major surgery within the next 30 days.

+10 more

Participant Groups

The study tests the GORE® EXCLUDER® Conformable AAA Endoprosthesis's safety and effectiveness in treating infrarenal abdominal aortic aneurysms. The endoprosthesis performance will be evaluated against specific goals to determine its suitability as a treatment option.

2Treatment groups

Experimental Treatment

Group I: Short Neck SubstudyExperimental Treatment1 Intervention

Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.

Group II: High Neck Angulation SubstudyExperimental Treatment1 Intervention

Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.