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

Primary Purpose

Abdominal Aortic Aneurysm (AAA)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nellix System
Sponsored by
Endologix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm (AAA) focused on measuring Infrarenal, Abdominal, Aortic, Aneurysm, AAA, Endologix, EVAS, EndoVascular, Sealing, System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Tucson Medical Center
  • VA San Diego
  • Yale University
  • Christiana Care Hospital
  • MedStar Health Research Institute
  • Baptist Hospital of Miami
  • Sacred Heart
  • St. Vincent Heart Center of Indiana
  • Maine Medical Center
  • St. Elizabeth's Medical Center
  • Bay State Hospital
  • Spectrum Health
  • Minneapolis Hospital
  • St. Vincent Heart and Vascular Center of Montana
  • Nebraska Heart Institute
  • Cooper Hospital
  • Carolinas Health Care
  • Cleveland Clinic
  • Ohio Health Research Institute
  • Allegheny General Hospital
  • UPMC Heart and Vascular Institue
  • St. Luke's Medical Center
  • The Heart Hospital Baylor Plano
  • Scott & White Healthcare System
  • Inova Fairfax Hospital
  • Providence Sacred Heart Medical Center
  • Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)
  • University of Heidelberg
  • Rijnstate Hospital
  • Addenbrooke's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nellix System

Arm Description

Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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
Clinical Utility Outcomes
anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time
Time in ICU
Number of hours spent in the intensive care unit (ICU)
Adverse Events
All serious and non-serious events within 30 days, at 6 months, and at 1 to 5 years
Aneurysm Rupture
Conversion to Open-Surgical Repair
Device Performance
aneurysm sac diameter change from the first post-operative CT scan, device migration, device patency, device integrity, incidence of endoleak
Mortality
Renal Dysfunction
assessment of estimated glomerular filtration rate (eGFR)
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.
Time to Hospital Discharge
Number of days spent in hospital

Full Information

First Posted
October 19, 2012
Last Updated
February 21, 2023
Sponsor
Endologix
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1. Study Identification

Unique Protocol Identification Number
NCT01726257
Brief Title
Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
Acronym
EVAS IDE
Official Title
Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endologix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm (AAA)
Keywords
Infrarenal, Abdominal, Aortic, Aneurysm, AAA, Endologix, EVAS, EndoVascular, Sealing, System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nellix System
Arm Type
Experimental
Arm Description
Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.
Intervention Type
Device
Intervention Name(s)
Nellix System
Intervention Description
Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.
Primary Outcome Measure Information:
Title
Major Adverse Events at 30 Days
Description
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
Time Frame
30 days
Title
Treatment Success at 1 Year
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Major Adverse Events From 30 days to 5 years
Description
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
Time Frame
>30 days to 5 years
Title
Clinical Utility Outcomes
Description
anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time
Time Frame
At the time of procedure
Title
Time in ICU
Description
Number of hours spent in the intensive care unit (ICU)
Time Frame
Up to 7 days
Title
Adverse Events
Description
All serious and non-serious events within 30 days, at 6 months, and at 1 to 5 years
Time Frame
> 30 days to 5 years
Title
Aneurysm Rupture
Time Frame
> 30 days to 5 years
Title
Conversion to Open-Surgical Repair
Time Frame
>30 days to 5 years
Title
Device Performance
Description
aneurysm sac diameter change from the first post-operative CT scan, device migration, device patency, device integrity, incidence of endoleak
Time Frame
> 30 days to 5 years
Title
Mortality
Time Frame
> 30 days to 5 years
Title
Renal Dysfunction
Description
assessment of estimated glomerular filtration rate (eGFR)
Time Frame
Post-procedure to 5 years
Title
Secondary Surgical Intervention
Description
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.
Time Frame
Post-procedure to 5 years
Title
Time to Hospital Discharge
Description
Number of days spent in hospital
Time Frame
Up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Carpenter, MD
Organizational Affiliation
Cooper Hospital, Camden, NJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tucson Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
VA San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Facility Name
Christiana Care Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
MedStar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Sacred Heart
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46077
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Bay State Hospital
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Minneapolis Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
St. Vincent Heart and Vascular Center of Montana
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Cooper Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08102
Country
United States
Facility Name
Carolinas Health Care
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UPMC Heart and Vascular Institue
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Scott & White Healthcare System
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Providence Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
90
Country
Netherlands
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22885361
Citation
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.
Results Reference
background
PubMed Identifier
21497521
Citation
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.
Results Reference
background
PubMed Identifier
32035772
Citation
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.
Results Reference
derived
PubMed Identifier
29609994
Citation
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.
Results Reference
derived
PubMed Identifier
26482997
Citation
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.
Results Reference
derived

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

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