Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System (EVAS1)

February 27, 2025 updated by: Endologix

Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access Study

The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).

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 outcomes generalizability. 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.
333

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

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, D-69120
        • University of Heidelberg
  • Netherlands
      • Arnhem, Netherlands, 90
        • Rijnstate Hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Tucson Medical Center
    • California
      • San Diego, California, United States, 92161
        • VA San Diego
    • Connecticut
      • New Haven, Connecticut, United States, 06437
        • Yale University
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Health Research Institute
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
      • Pensacola, Florida, United States, 32504
        • Sacred Heart
    • Indiana
      • Indianapolis, Indiana, United States, 46077
        • St. Vincent Heart Center of Indiana
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • St. Elizabeth's Medical Center
      • Springfield, Massachusetts, United States, 01199
        • Bay State Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Spectrum Health
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Hospital
    • Montana
      • Billings, Montana, United States, 59101
        • St. Vincent Heart and Vascular Center of Montana
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • New Jersey
      • Camden, New Jersey, United States, 08102
        • Cooper Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Health Care
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43214
        • Ohio Health Research Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Heart and Vascular Institue
    • Texas
      • Houston, Texas, United States, 77030
        • St. Luke's Medical Center
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
      • Temple, Texas, United States, 76508
        • Scott & White Healthcare System
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)

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:

  • Male or female at least 18 years old;
  • Informed consent understood and signed;
  • Patient agrees to all follow-up visits;
  • Have AAA with sac diameter ≥5.0cm, or ≥4.5 cm which has increased by >1.0cm in the past year.
  • Anatomic eligibility for the Nellix System per the instructions for use:
  • Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
  • Aneurysm blood lumen diameter ≤60mm;
  • Most caudal renal artery to aortoiliac bifurcation length ≥100mm;
  • Proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 18 to 32mm; angle ≤60° to the aneurysm sac;
  • Common iliac artery lumen diameter between 9 and 35mm with blood lumen diameter ≤35mm;
  • Ability to preserve at least one hypogastric artery.

Exclusion Criteria:

  • Life expectancy <2 years;
  • Psychiatric or other condition that may interfere with the study;
  • Participating in enrollment of another clinical study
  • Known allergy to device any device component;
  • Coagulopathy or uncontrolled bleeding disorder;
  • Ruptured, leaking or mycotic aneurysm;
  • Serum creatinine level >2.0mg/dL;
  • CVA or MI within three months of enrollment/treatment;
  • Aneurysmal disease of the descending thoracic aorta;
  • Clinically significant infrarenal mural thrombus (>5mm thickness over >50% circumference);
  • Connective tissue diseases (e.g., Marfan Syndrome)
  • Unsuitable vascular anatomy;
  • Pregnant (females 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.
Experimental: Nellix System
Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.
Device: Nellix System
Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.

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
Major Adverse Events at 30 Days
Time Frame: 30 days
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
30 days
Treatment Success at 1 Year
Time Frame: 1 year
Procedural technical success and the absence of aneurysm rupture, conversion to open surgical repair, Type I endoleak at 12 months, Type III endoleak at 12 months, aneurysm enlargement, secondary procedure for resolution of endoleak (Type I or III), limb occlusion, migration, aneurysm sac expansion and/or a device defect.
1 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
Major Adverse Events From 30 days to 5 years
Time Frame: >30 days to 5 years
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
>30 days to 5 years
Clinical Utility Outcomes
Time Frame: At the time of procedure
anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time
At the time of procedure
Time in ICU
Time Frame: Up to 7 days
Number of hours spent in the intensive care unit (ICU)
Up to 7 days
Adverse Events
Time Frame: > 30 days to 5 years
All serious and non-serious events within 30 days, at 6 months, and at 1 to 5 years
> 30 days to 5 years
Aneurysm Rupture
Time Frame: > 30 days to 5 years
> 30 days to 5 years
Conversion to Open-Surgical Repair
Time Frame: >30 days to 5 years
>30 days to 5 years
Device Performance
Time Frame: > 30 days to 5 years
aneurysm sac diameter change from the first post-operative CT scan, device migration, device patency, device integrity, incidence of endoleak
> 30 days to 5 years
Mortality
Time Frame: > 30 days to 5 years
> 30 days to 5 years
Renal Dysfunction
Time Frame: Post-procedure to 5 years
assessment of estimated glomerular filtration rate (eGFR)
Post-procedure to 5 years
Secondary Surgical Intervention
Time Frame: Post-procedure to 5 years
The number of additional surgical procedures to repair resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defects will be collected.
Post-procedure to 5 years
Time to Hospital Discharge
Time Frame: Up to 7 days
Number of days spent in hospital
Up to 7 days

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, Camden, NJ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2013

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 1, 2016

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.
December 1, 2022

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).
October 19, 2012

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.
November 9, 2012

First Posted (Estimated)

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.
November 14, 2012

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.
March 25, 2025

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.
February 27, 2025

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.
February 1, 2025

More Information

Terms related to this study

Keywords

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

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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