Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.
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 safety and effectiveness outcomes. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Safety: Major Adverse Events (MAE)
The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Renal Failure; Respiratory Failure; Stroke; Procedural Blood Loss ≥1,000cc
Time frame: 30 days
Effectiveness: Rate of Treatment Success
The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows: It is defined as procedural technical success and absence of Abdominal aortic aneurysm rupture; Conversion to open surgical repair; Endoleak Type I or III at year 2; Clinically significant migration; \> 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference from the 30-Day CT time point; or Secondary endovascular procedure up to year 2 for resolution of Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect.
Time frame: 2 year
Conversions, Death and Ruptures
Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023,
Time frame: 2 Years
Device Integrity
Device Integrity is defined as the absence of device fracture, stenosis, kink, occlusion, or migration \>5mm. All incidences of stent occlusion (100% device lumen obstruction) are also captured as stent stenosis (\<100% device lumen obstruction).
Time frame: 2 Years
Device Performance - Endoleak
Demonstrates device performance as indicated by the incidence of Endoleaks through study follow-up. Endoleak is determined by the CoreLab based on imaging completed. Endoleak is defined as clear evidence of contrast outside of one or both EndoBags which communicates with the aneurysm sac originating proximally at the infrarenal segment (Type IA), distally (Type IB); between components, if an extender is used (Type III); trans-device (Type IV); or from a patent collateral vessel (Type II: e.g., lumbar artery; inferior mesenteric artery).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Valley Vascular Consultants
Huntsville, Alabama, United States
Regents of the University of California (UCLA)
Los Angeles, California, United States
Veterans Medical Research Foundation
San Diego, California, United States
UC Health-Memorial Hospital
Colorado Springs, Colorado, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Miami Cardiac & Vascular Institute (MCVI)
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Coastal Vascular & Interventional
Pensacola, Florida, United States
Christie Clinic
Champaign, Illinois, United States
AMITA Health
Elk Grove Village, Illinois, United States
...and 17 more locations
Time frame: 2 Years
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size
Average Sac Diameter size at Visit
Time frame: 2 years
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month
Number of subjects that had changes in the Sac Diameter size since the 1 month follow-up visit
Time frame: 2 Years
Secondary Interventions
All Secondary interventions reported during the study
Time frame: 2 Years
LABS-RENAL FUNCTION (EGFR)
The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit
Time frame: 2 Years
LABS- RENAL FUNCTION (CREATININE)
Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit
Time frame: 2 Years