N/A
N=333
Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
Abdominal Aortic Aneurysm (AAA)
Bottom Line
View on ClinicalTrials.gov: NCT01726257 ↗Enrolled (actual)
333
Serious AEs
20.4%
Results posted
Nov 2024
Primary outcome: Primary: Major Adverse Events at 30 Days — 4; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nellix System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endologix
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Events at 30 Days |
4; 1; 2 | — |
| PRIMARY Treatment Success at 1 Year |
126; 22; 94 | — |
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).
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 2.0mg/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).
Data sourced from ClinicalTrials.gov (NCT01726257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.