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

Primary Purpose

Abdominal Aortic Aneurysm Without Rupture

Status
Active
Phase
Not Applicable
Locations
United States
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 Without Rupture

Eligibility Criteria

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

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).

Sites / Locations

  • Valley Vascular Consultants
  • Regents of the University of California (UCLA)
  • Veterans Medical Research Foundation
  • UC Health-Memorial Hospital
  • MedStar Health Research Institute
  • Miami Cardiac & Vascular Institute (MCVI)
  • AdventHealth Orlando
  • Coastal Vascular & Interventional
  • Christie Clinic
  • AMITA Health
  • St. Vincent Heart Center of Indiana
  • Massachusetts General Hospital
  • McLaren Bay Region
  • Midwest Aortic & Vascular Institute
  • The Cooper Health System
  • New Mexico Heart Institute
  • Icahn School of Medicine at Mount Sinai
  • Cleveland Clinic
  • Northeast Ohio Vascular Assoc (NEOVA)
  • OU College of Medicine
  • Providence St. Vincent Medical Center
  • Palmetto Health- University of South Carolina
  • Wellmont CVA Heart Institute
  • Cardiovascular Surgery Clinic
  • Inova Research Center
  • Providence Sacred Heart Medical Center
  • Aspirus Research Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System

Outcomes

Primary Outcome Measures

Incidence of Major Adverse Events (MAE)
All cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1,000cc
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

Secondary Outcome Measures

Full Information

First Posted
September 27, 2017
Last Updated
September 30, 2021
Sponsor
Endologix
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1. Study Identification

Unique Protocol Identification Number
NCT03298477
Brief Title
EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
Acronym
EVAS2
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
August 17, 2022 (Anticipated)
Study Completion Date
August 16, 2025 (Anticipated)

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm Without Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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. Sites have been chosen with a suitable research infrastructure and physician experience in endovascular aneurysm repair to ensure adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System
Intervention Type
Device
Intervention Name(s)
Nellix® System
Intervention Description
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Primary Outcome Measure Information:
Title
Incidence of Major Adverse Events (MAE)
Description
All cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1,000cc
Time Frame
30 days
Title
Rate of Treatment Success
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA A patient who meets all of the following criteria potentially may be included in the study: Male or female at least 18 years old; Informed consent form understood and signed Patient agrees to all follow-up visits; 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. Anatomically eligible for the Nellix System (per Instructions For Use): Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm); Aneurysm blood lumen diameter ≤60mm; Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac; Most caudal renal artery to each hypogastric artery length ≥100mm; Common iliac artery lumen diameter between 9 and 35mm; Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm; Ability to preserve at least one hypogastric artery. 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: Life expectancy <2 years as judged by the Investigator; Psychiatric or other condition that may interfere with the study; Participating in another clinical study; Known allergy or contraindication to any device material; Coagulopathy or uncontrolled bleeding disorder; Ruptured, leaking or mycotic aneurysm; Serum creatinine (S-Cr) level >2.0 mg/dL; CVA or MI within three months of enrollment/treatment; Aneurysmal disease of the descending thoracic aorta; Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference); Connective tissue diseases (e.g., Marfan Syndrome); Unsuitable vascular anatomy that may interfere with device introduction or deployment; Pregnant (female of childbearing potential only).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Carpenter, MD
Organizational Affiliation
Cooper Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Vascular Consultants
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Regents of the University of California (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Veterans Medical Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
UC Health-Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
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
Miami Cardiac & Vascular Institute (MCVI)
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Coastal Vascular & Interventional
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Christie Clinic
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
AMITA Health
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
McLaren Bay Region
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
Midwest Aortic & Vascular Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
The Cooper Health System
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Northeast Ohio Vascular Assoc (NEOVA)
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44095
Country
United States
Facility Name
OU College of Medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Palmetto Health- University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Wellmont CVA Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Cardiovascular Surgery Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Inova Research Center
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
Aspirus Research Institute
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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