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Endovascular Repair

ChEVAS for Abdominal Aortic Aneurysm (ChEVAS One Trial)

N/A

Waitlist Available

Research Sponsored by Endologix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Abdominal aortic aneurysm (AAA) with specific size criteria

Be older than 18 years old

Must not have

Unsuitable vascular anatomy that may interfere with device introduction or deployment

Requirement of home oxygen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new endovascular repair system for complex abdominal aortic aneurysms. Subjects will be enrolled at multiple sites, and the trial will assess the safety and effectiveness of the device.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include complications related to endovascular procedures such as blood vessel damage, infection risk at the incision site, allergic reactions to materials used in the system or contrast media during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an abdominal aortic aneurysm of a specific size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I need oxygen at home.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure

Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met