N/A
N=98
EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
Abdominal Aortic Aneurysm Without Rupture
Bottom Line
View on ClinicalTrials.gov: NCT03298477 ↗Enrolled (actual)
98
Serious AEs
50.0%
Results posted
Mar 2025
Primary outcome: Primary: Safety: Major Adverse Events (MAE) — 1; 2; 2 Number of Events
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 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Major Adverse Events (MAE) |
1; 2; 2 | — |
| PRIMARY Effectiveness: Rate of Treatment Success |
92.2 | — |
| SECONDARY Conversions, Death and Ruptures |
0; 7; 0 | — |
| SECONDARY Device Integrity |
5; 4; 1; 0; 0; 0 | — |
| SECONDARY Device Performance - Endoleak |
5; 1; 6; 0; 0; 1 | — |
| SECONDARY DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size |
55.4 | — |
| SECONDARY DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month |
3; 69; 4; 72 | — |
| SECONDARY Secondary Interventions |
0; 1; 1; 1; 1; 1 | — |
| SECONDARY LABS-RENAL FUNCTION (EGFR) |
66 | — |
| SECONDARY LABS- RENAL FUNCTION (CREATININE) |
1.19 | — |
Summary
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.
Eligibility Criteria
INCLUSION CRITERIA
A patient who meets all of the following criteria potentially may be included in the study:
- Male or female at least 18 years old;
- Informed consent form understood and signed
- Patient agrees to all follow-up visits;
- Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA 2.0 mg/dL;
- CVA or MI within three months of enrollment/treatment;
- Aneurysmal disease of the descending thoracic aorta;
- Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);
- Connective tissue diseases (e.g., Marfan Syndrome);
- Unsuitable vascular anatomy that may interfere with device introduction or deployment;
- Pregnant (female of childbearing potential only).
Data sourced from ClinicalTrials.gov (NCT03298477). 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.