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

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: Active, not recruiting
• Conditions: Abdominal Aortic Aneurysm Without Rupture
• Intervention / Treatment: Device: Nellix® System

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: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

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, 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of Major Adverse Events (MAE)	All cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1,000cc	30 days
Rate of Treatment Success	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

Collaborators and Investigators

• Sponsor: Endologix
• Investigators: Principal Investigator: Jeffrey Carpenter, MD, Cooper Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): June 7, 2022
• Study Completion (Estimated): August 16, 2025

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Aortic Diseases; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID 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