EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study (EVAS2)

April 28, 2026 updated by: Endologix

Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess safety and effectiveness outcomes. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Valley Vascular Consultants
    • California
      • Los Angeles, California, United States, 90095
        • Regents of the University of California (UCLA)
      • San Diego, California, United States, 92161
        • Veterans Medical Research Foundation
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • UC Health-Memorial Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Health Research Institute
    • Florida
      • Miami, Florida, United States, 33176
        • Miami Cardiac & Vascular Institute (MCVI)
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Pensacola, Florida, United States, 32503
        • Coastal Vascular & Interventional
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Christie Clinic
      • Elk Grove Village, Illinois, United States, 60007
        • AMITA Health
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • St. Vincent Heart Center of Indiana
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Bay City, Michigan, United States, 48708
        • McLaren Bay Region
    • Missouri
      • Kansas City, Missouri, United States, 64116
        • Midwest Aortic & Vascular Institute
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • The Cooper Health System
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Willoughby, Ohio, United States, 44095
        • Northeast Ohio Vascular Assoc (NEOVA)
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • OU College of Medicine
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence St. Vincent Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health- University of South Carolina
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Wellmont CVA Heart Institute
      • Memphis, Tennessee, United States, 38120
        • Cardiovascular Surgery Clinic
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Research Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart Medical Center
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA

A patient who meets all of the following criteria potentially may be included in the study:

  1. Male or female at least 18 years old;
  2. Informed consent form understood and signed
  3. Patient agrees to all follow-up visits;
  4. Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.

  5. Anatomically eligible for the Nellix System (per Instructions For Use):

    1. Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
    2. Aneurysm blood lumen diameter ≤60mm;
    3. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;
    4. Most caudal renal artery to each hypogastric artery length ≥100mm;
    5. Common iliac artery lumen diameter between 9 and 35mm;
    6. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;
    7. Ability to preserve at least one hypogastric artery.
    8. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.40

EXCLUSION CRITERIA

A patient who meets none of the following criteria potentially may be included in the study:

  1. Life expectancy <2 years as judged by the Investigator;
  2. Psychiatric or other condition that may interfere with the study;
  3. Participating in another clinical study;
  4. Known allergy or contraindication to any device material;
  5. Coagulopathy or uncontrolled bleeding disorder;
  6. Ruptured, leaking or mycotic aneurysm;
  7. Serum creatinine (S-Cr) level >2.0 mg/dL;
  8. CVA or MI within three months of enrollment/treatment;
  9. Aneurysmal disease of the descending thoracic aorta;
  10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);
  11. Connective tissue diseases (e.g., Marfan Syndrome);
  12. Unsuitable vascular anatomy that may interfere with device introduction or deployment;
  13. Pregnant (female of childbearing potential only).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single Arm
Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System
Device: Nellix® System
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety: Major Adverse Events (MAE)
Time Frame: 30 days
The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Renal Failure; Respiratory Failure; Stroke; Procedural Blood Loss ≥1,000cc
30 days
Effectiveness: Rate of Treatment Success
Time Frame: 2 year

The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows:

It is defined as procedural technical success and absence of Abdominal aortic aneurysm rupture; Conversion to open surgical repair; Endoleak Type I or III at year 2; Clinically significant migration; > 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference from the 30-Day CT time point; or Secondary endovascular procedure up to year 2 for resolution of Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect.
2 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Conversions, Death and Ruptures
Time Frame: 2 Years
Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023,
2 Years
Device Integrity
Time Frame: 2 Years
Device Integrity is defined as the absence of device fracture, stenosis, kink, occlusion, or migration >5mm. All incidences of stent occlusion (100% device lumen obstruction) are also captured as stent stenosis (<100% device lumen obstruction).
2 Years
Device Performance - Endoleak
Time Frame: 2 Years
Demonstrates device performance as indicated by the incidence of Endoleaks through study follow-up. Endoleak is determined by the CoreLab based on imaging completed. Endoleak is defined as clear evidence of contrast outside of one or both EndoBags which communicates with the aneurysm sac originating proximally at the infrarenal segment (Type IA), distally (Type IB); between components, if an extender is used (Type III); trans-device (Type IV); or from a patent collateral vessel (Type II: e.g., lumbar artery; inferior mesenteric artery).
2 Years
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size
Time Frame: 2 years
Average Sac Diameter size at Visit
2 years
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month
Time Frame: 2 Years
Number of subjects that had changes in the Sac Diameter size since the 1 month follow-up visit
2 Years
Secondary Interventions
Time Frame: 2 Years
All Secondary interventions reported during the study
2 Years
LABS-RENAL FUNCTION (EGFR)
Time Frame: 2 Years
The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit
2 Years
LABS- RENAL FUNCTION (CREATININE)
Time Frame: 2 Years
Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endologix

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey Carpenter, MD, Cooper Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP-0008 EVAS2 IDE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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