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

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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
Washington, District of Columbia 20010
Principal Investigator: Nelson Bernardo, MD
Phone: 202-877-8475
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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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...
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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...
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Billings, Montana 59101
Principal Investigator: Kevin Bruen, MD
Phone: 406-238-6859
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Brighton, Massachusetts 02135
Principal Investigator: Nikhil Kansal, MD, FACS
Phone: 617-779-6504
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Camden, New Jersey 08102
Principal Investigator: Jose Trani, MD
Phone: 856-342-2150
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Charlotte, North Carolina 28207
Principal Investigator: Frank Arko, MD
Phone: 704-355-4794
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Columbus, Ohio 43214
Phone: 614-566-1252
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Grand Rapids, Michigan 49503
Principal Investigator: Robert Cuff, MD
Phone: 616-391-0556
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Heidelberg, Baden-Württemberg 69120
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Houston, Texas 77030
Principal Investigator: Zvonimir Krajcer, MD
Phone: 832-355-3710
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Indianapolis, Indiana 46260
Principal Investigator: Sajjad Hussain, MD
Phone: 317-583-6313
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Lincoln, Nebraska 68526
Principal Investigator: Steve Tyndall, MD
Phone: 402-328-3946
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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...
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Milwaukee, Wisconsin 53226
Principal Investigator: Cheong Jun Lee, MD
Phone: 414-805-5085
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Minneapolis, Minnesota 55407
Principal Investigator: Timothy Sullivan, MD
Phone: 612.863.3793
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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...
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Newark, Delaware 19718
Phone: 302-733-4112
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Pensacola, Florida 32504
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Pittsburg, Pennsylvania 15232
Principal Investigator: Michel Makaroun, MD
Phone: 412-623-8452
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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...
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Plano, Texas 75093
Principal Investigator: Javier Vasquez, MD
Phone: 469-814-4712
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San diego, California 92161
Principal Investigator: John Lane, MD
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Spokane, Washington 99204
Principal Investigator: Stephen Murray, MD, FACS
Phone: 509-474-4320
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Springfield, Massachusetts
Principal Investigator: Neal Hadro, MD
Phone: 413-794-8704
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Temple, Texas 76508
Phone: 254-724-9248
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Tucson, Arizona 85712
Principal Investigator: Luis Leon, MD
Phone: 520-882-7117
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