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



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:December 2013
End Date:June 2021
Contact:Peter Miller
Email:pmiller@endologix.com
Phone:949-595-7200

Use our guide to learn which trials are right for you!

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).

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.

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 ≥5.5cm, 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 16 to 32mm; angle
≤60° to the aneurysm sac;

- Common iliac artery lumen diameter between 8 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).
We found this trial at
28
sites
Charlotte, North Carolina 28207
Principal Investigator: Frank Arko, MD
Phone: 704-355-4794
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Phone: 703-776-8085
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Christopher Healey, MD, FACS
Phone: 207-661-7646
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
?
mi
from
Portland, ME
Click here to add this to my saved trials
Billings, Montana 59101
Principal Investigator: Kevin Bruen, MD
Phone: 406-238-6859
?
mi
from
Billings, MT
Click here to add this to my saved trials
Brighton, Massachusetts 02135
Principal Investigator: Nikhil Kansal, MD, FACS
Phone: 617-779-6504
?
mi
from
Brighton, MA
Click here to add this to my saved trials
Camden, New Jersey 08102
Principal Investigator: Jose Trani, MD
Phone: 856-342-2150
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Columbus, Ohio 43214
Phone: 614-566-1252
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
Principal Investigator: Robert Cuff, MD
Phone: 616-391-0556
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Heidelberg, Baden-Württemberg 69120
?
mi
from
Heidelberg,
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Zvonimir Krajcer, MD
Phone: 832-355-3710
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
Principal Investigator: Sajjad Hussain, MD
Phone: 317-583-6313
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Lincoln, Nebraska 68526
Principal Investigator: Steve Tyndall, MD
Phone: 402-328-3946
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
Principal Investigator: James Benenati, MD, FSIR
Phone: 786-596-5972
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53226
Principal Investigator: Cheong Jun Lee, MD
Phone: 414-805-5085
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55407
Principal Investigator: Timothy Sullivan, MD
Phone: 612.863.3793
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-785-2564
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Newark, Delaware 19718
Phone: 302-733-4112
?
mi
from
Newark, DE
Click here to add this to my saved trials
Pensacola, Florida 32504
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Pittsburg, Pennsylvania 15232
Principal Investigator: Michel Makaroun, MD
Phone: 412-623-8452
?
mi
from
Pittsburg, PA
Click here to add this to my saved trials
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Phone: 412-359-3253
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plano, Texas 75093
Principal Investigator: Javier Vasquez, MD
Phone: 469-814-4712
?
mi
from
Plano, TX
Click here to add this to my saved trials
San diego, California 92161
Principal Investigator: John Lane, MD
?
mi
from
San diego, CA
Click here to add this to my saved trials
Spokane, Washington 99204
Principal Investigator: Stephen Murray, MD, FACS
Phone: 509-474-4320
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Springfield, Massachusetts
Principal Investigator: Neal Hadro, MD
Phone: 413-794-8704
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Temple, Texas 76508
Phone: 254-724-9248
?
mi
from
Temple, TX
Click here to add this to my saved trials
Tucson, Arizona 85712
Principal Investigator: Luis Leon, MD
Phone: 520-882-7117
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Washington, District of Columbia 20010
Principal Investigator: Nelson Bernardo, MD
Phone: 202-877-8475
?
mi
from
Washington,
Click here to add this to my saved trials