ChEVAS for Abdominal Aortic Aneurysm (ChEVAS One Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Endologix

No Placebo Group

Trial Summary

What is the purpose of this trial?Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.

Eligibility Criteria

This trial is for adults over 18 with abdominal aortic aneurysms meeting specific size criteria and without significant vessel angulation. Candidates must consent to follow-up visits, not be in other studies within the last 30 days, have no allergies to materials used, or conditions like Marfan Syndrome that could affect results.

Inclusion Criteria

I have an abdominal aortic aneurysm of a specific size.

Exclusion Criteria

My blood vessels may not allow for safe medical device use.

I need oxygen at home.

I have a stent in a major artery that could affect new treatment.

Treatment Details

The study tests the ChEVAS System for repairing complex abdominal aortic aneurysms. It's prospective and non-randomized, meaning all eligible participants at each center get the new treatment without being compared to another group receiving a different treatment.

1Treatment groups

Experimental Treatment

Group I: ChEVAS SystemExperimental Treatment1 Intervention

The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.