Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Interventions
- Device: Nellix System
- Registration Number
- NCT01726257
- Lead Sponsor
- Endologix
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nellix System Nellix System Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.
- Primary Outcome Measures
Name Time Method Major Adverse Events at 30 Days 30 days Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss \>1,000cc
Treatment Success at 1 Year 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Maine Medical Center
🇺🇸Portland, Maine, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, 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
Yale University
🇺🇸New Haven, Connecticut, United States
MedStar Health Research Institute
🇺🇸Washington, District of Columbia, United States
Christiana Care Hospital
🇺🇸Newark, Delaware, United States
VA San Diego
🇺🇸San Diego, California, United States
Tucson Medical Center
🇺🇸Tucson, Arizona, 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
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
Cooper Hospital
🇺🇸Camden, New Jersey, United States
St. Vincent Heart and Vascular Center of Montana
🇺🇸Billings, Montana, United States
Carolinas Health Care
🇺🇸Charlotte, North Carolina, United States
Providence Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
University of Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)
🇺🇸Milwaukee, Wisconsin, United States
Scott & White Healthcare System
🇺🇸Temple, Texas, United States
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States