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Endovascular Aneurysm Repair Device

Nellix System for Abdominal Aortic Aneurysm (EVAS2 Trial)

N/A
Waitlist Available
Led By Jeffrey Carpenter, MD
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 with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.
Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm
Must not have
Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference)
Unsuitable vascular anatomy that may interfere with device introduction or deployment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will prospectively study the Nellix System in subjects with abdominal aortic aneurysms. The trial will be single arm and multicenter, meaning multiple sites will enroll eligible subjects consecutively. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, endovascular procedures can generally cause reactions such as bleeding, infection risk at the incision site, potential damage to blood vessels, and sometimes may lead to further interventions if complications occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My abdominal aortic aneurysm is larger than 5.0cm, or it has grown by more than 0.5cm in the last 6 months.
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My iliac artery is the right size for the procedure.
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One of my hypogastric arteries can be saved.
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My aorta near the aneurysm is not enlarged, is 10-28mm wide, and angles ≤60°.
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My blood vessels are wide enough for the needed medical equipment.
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My common iliac artery is between 9 and 35mm wide.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a significant blood clot in the area where my abdominal aorta meets my kidneys.
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My blood vessels may not allow for certain medical device procedures.
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I have an aneurysm in the upper part of my aorta.
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I have a bleeding disorder that is not under control.
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I have a ruptured or infected aneurysm.

Timeline

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
Incidence of Major Adverse Events (MAE)
Rate of Treatment Success

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: Single ArmExperimental Treatment1 Intervention
Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System

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Who is running the clinical trial?

EndologixLead Sponsor
22 Previous Clinical Trials
3,912 Total Patients Enrolled
Jeffrey Carpenter, MDPrincipal InvestigatorCooper Hospital
1 Previous Clinical Trials
430 Total Patients Enrolled
~12 spots leftby Nov 2025
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