Nellix System for Abdominal Aortic Aneurysm
(EVAS2 Trial)

Recruiting in Palo Alto (17 mi)

+30 other locations

Overseen byJeffrey Carpenter, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Endologix

No Placebo Group

Trial Summary

What is the purpose of this trial?Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

Eligibility Criteria

This trial is for adults with abdominal aortic aneurysms that are large or growing quickly, who have suitable blood vessel anatomy for the Nellix System. Participants must understand and sign consent forms, agree to follow-up visits, and not be pregnant or have certain health conditions like severe kidney issues or recent heart attacks.

Inclusion Criteria

I am 18 years old or older.

My abdominal aortic aneurysm is larger than 5.0cm, or it has grown by more than 0.5cm in the last 6 months.

Informed consent form understood and signed

+10 more

Exclusion Criteria

I have a significant blood clot in the area where my abdominal aorta meets my kidneys.

Psychiatric or other condition that may interfere with the study

Participating in another clinical study

+10 more

Participant Groups

The study is testing the safety and effectiveness of the Nellix System in repairing abdominal aortic aneurysms. It's a single group study where all participants will receive this endovascular repair procedure at various medical centers.

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System