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

NCT ID: NCT01726257

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2022-12-31

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).

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 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.

Conditions

Abdominal Aortic Aneurysm (AAA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nellix System

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

Group Type: EXPERIMENTAL

Nellix System

Intervention Type: DEVICE

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

Interventions

Nellix System

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

Intervention Type: DEVICE

Eligibility Criteria

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 ≥5.0cm, 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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endologix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Carpenter, MD

Role: PRINCIPAL_INVESTIGATOR

Cooper Hospital, Camden, NJ

Locations

Tucson Medical Center

Tucson, Arizona, United States

VA San Diego

San Diego, California, United States

Yale University

New Haven, Connecticut, United States

Christiana Care Hospital

Newark, Delaware, United States

MedStar Health Research Institute

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

Baptist Hospital of Miami

Miami, Florida, United States

Sacred Heart

Pensacola, Florida, United States

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, United States

Maine Medical Center

Portland, Maine, United States

St. Elizabeth's Medical Center

Brighton, Massachusetts, United States

Bay State Hospital

Springfield, Massachusetts, United States

Spectrum Health

Grand Rapids, Michigan, United States

Minneapolis Hospital

Minneapolis, Minnesota, United States

St. Vincent Heart and Vascular Center of Montana

Billings, Montana, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

Cooper Hospital

Camden, New Jersey, United States

Carolinas Health Care

Charlotte, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio Health Research Institute

Columbus, Ohio, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

UPMC Heart and Vascular Institue

Pittsburgh, Pennsylvania, United States

St. Luke's Medical Center

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Scott & White Healthcare System

Temple, Texas, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)

Milwaukee, Wisconsin, United States

University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Rijnstate Hospital

Arnhem, , Netherlands

Addenbrooke's Hospital

Cambridge, , United Kingdom

Countries

United States; Germany; Netherlands; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 22885361 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21497521 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32035772 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29609994 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26482997 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP-0008

Identifier Type: -

Identifier Source: org_study_id