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

NCT01726257 | Completed Results DMC FDA Device

• 1 other identifier: CP-0008
• Study Type: interventional
• Target: 333
• Locations: 4 countries
• Sites: 30

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).

Conditions

Abdominal Aortic Aneurysm (AAA)

Keywords

Infrarenal; Abdominal; Aortic; Aneurysm; AAA; Endologix; EVAS; EndoVascular; Sealing; System

Outcome Measures

Primary Outcomes (2)

• 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

  30 days

• Treatment Success at 1 Year

  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.

  1 year

Study Arms (1)

Nellix System

EXPERIMENTAL

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

Device: Nellix System

Interventions

Nellix System DEVICE

Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.

Nellix System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Endologix: lead

Study Sites (30)

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

VA San Diego

San Diego, California, 92161, United States

Location

Yale University

New Haven, Connecticut, 06437, United States

Location

Christiana Care Hospital

Newark, Delaware, 19713, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Sacred Heart

Pensacola, Florida, 32504, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46077, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

Bay State Hospital

Springfield, Massachusetts, 01199, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49546, United States

Location

Minneapolis Hospital

Minneapolis, Minnesota, 55407, United States

Location

St. Vincent Heart and Vascular Center of Montana

Billings, Montana, 59101, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Cooper Hospital

Camden, New Jersey, 08102, United States

Location

Carolinas Health Care

Charlotte, North Carolina, 28203, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Heart and Vascular Institue

Pittsburgh, Pennsylvania, 15232, United States

Location

St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Scott & White Healthcare System

Temple, Texas, 76508, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)

Milwaukee, Wisconsin, 53226, United States

Location

University of Heidelberg

Heidelberg, Baden-Wurttemberg, D-69120, Germany

Location

Rijnstate Hospital

Arnhem, 90, Netherlands

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 22885361 BACKGROUND

• 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.

  PMID: 21497521 BACKGROUND

• 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.

  PMID: 32035772 DERIVED

• 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.

  PMID: 29609994 DERIVED

• 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.

  PMID: 26482997 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Tammy Stiver
• Organization: Endologix

tstiver@endologix.com

5136731452

Study Officials

• Jeffrey Carpenter, MD

  Cooper Hospital, Camden, NJ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: November 14, 2012
• Study Start: December 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2022
• Last Updated: February 28, 2025
• Results First Posted: November 6, 2024

Record last verified: 2025-02

Locations

DE (1); NL (1); US (27); GB (1)