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



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:December 1, 2017
End Date:May 2024
Contact:Helen Van
Email:hvan@endologix.com
Phone:949-452-2532

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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.

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.

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).
We found this trial at
24
sites
Indianapolis, Indiana 46290
Principal Investigator: Sajjad Hussain
Phone: 317-583-6313
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Levester Kirksey, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Alok Gupta, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Albuquerque, New Mexico 87102
Principal Investigator: Esteban Henao, MD
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Bay City, Michigan 48708
Principal Investigator: Nicolas Mouawad, MD
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Boston, Massachusetts 02114
Principal Investigator: Chris Kwolek, MD
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Buffalo, New York 14215
Principal Investigator: Richard Curl, MD
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Camden, New Jersey 08103
Principal Investigator: Joseph Lombardi, MD
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7 Richland Medical Park Drive
Columbia, South Carolina 29208
Principal Investigator: Firas Mussa, MD
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Falls Church, Virginia 22042
Principal Investigator: Homayoun Hashemi, MD
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Grand Rapids, Michigan 49503
Principal Investigator: Robert Cuff, MD
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Huntsville, Alabama 35801
Principal Investigator: Fred Stucky
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Kansas City, Missouri 64116
Principal Investigator: Scott Kujath
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Kingsport, Tennessee 37660
Principal Investigator: Christopher Metzger, MD
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Los Angeles, California 90095
Principal Investigator: William Quinones-Baldrich, MD
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Memphis, Tennessee 38120
Principal Investigator: Edward Garrett, MD
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Milwaukee, Wisconsin 53215
Principal Investigator: Mark Mewissen, MD
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: James McKinsey, MD
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Orlando, Florida 32803
Principal Investigator: Manny Perez-Izquierdo, MD
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Pensacola, Florida 32204
Principal Investigator: Huey McDaniel, MD
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9205 SW Barnes Rd
Portland, Oregon 97225
(503) 216-1234
Principal Investigator: Brant Ullery, MD
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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Spokane, Washington 99204
Principal Investigator: Stephen Murray, MD
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Washington, District of Columbia 20010
Principal Investigator: Nelson Bernardo
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Willoughby, Ohio 44095
Principal Investigator: Vikram Rao, MD
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