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

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: Completed
• Conditions: Abdominal Aortic Aneurysm (AAA)
• 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 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: Interventional
• Enrollment (Actual): 333
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

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
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

Outcome Measure	Measure Description	Time Frame
Major Adverse Events at 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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Events From 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	anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time	At the time of procedure
Time in ICU	Number of hours spent in the intensive care unit (ICU)	Up to 7 days
Adverse Events	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		> 30 days to 5 years
Conversion to Open-Surgical Repair		>30 days to 5 years
Device Performance	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		> 30 days to 5 years
Renal Dysfunction	assessment of estimated glomerular filtration rate (eGFR)	Post-procedure to 5 years
Secondary Surgical Intervention	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	Number of days spent in hospital	Up to 7 days

Collaborators and Investigators

• Sponsor: Endologix

Publications and helpful links

General Publications

• Kisis K, Krievins D, Naskovica K, Gedins M, Savlovskis J, Ezite N, Lietuvietis E, Zarins K. Quality of life after endovascular abdominal aortic aneurysm repair: nellix sac-anchoring endoprosthesis versus open surgery. Medicina (Kaunas). 2012;48(6):286-91.
• Krievins DK, Holden A, Savlovskis J, Calderas C, Donayre CE, Moll FL, Katzen B, Zarins CK. EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):38-46. doi: 10.1016/j.ejvs.2011.03.007. Epub 2011 Apr 15.
• Carpenter JP, Lane JS 3rd, Trani J, Hussain S, Healey C, Hashemi H, Cuff R; Nellix Investigators. Proper technical procedures improved outcomes in a retrospective analysis of EVAS FORWARD IDE trial 3-year results. J Vasc Surg. 2020 Sep;72(3):918-930.e2. doi: 10.1016/j.jvs.2019.11.039. Epub 2020 Feb 5.
• Carpenter JP, Lane JS 3rd, Trani J, Hussain S, Healey C, Buckley CJ, Hashemi H, Cuff R; Nellix Investigators. Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial. J Vasc Surg. 2018 Sep;68(3):720-730.e1. doi: 10.1016/j.jvs.2018.01.031. Epub 2018 Mar 31.
• Carpenter JP, Cuff R, Buckley C, Healey C, Hussain S, Reijnen MM, Trani J, Bockler D; Nellix Investigators. Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing. J Vasc Surg. 2016 Jan;63(1):23-31.e1. doi: 10.1016/j.jvs.2015.07.096. Epub 2015 Oct 21.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: October 19, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (Estimate): November 14, 2012

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Aneurysm; Abdominal; AAA; Aortic; EVAS; Endologix; Infrarenal; System; EndoVascular; Sealing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID 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