Trial Outcomes & Findings for Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System (NCT NCT01726257)
NCT ID: NCT01726257
Last Updated: 2025-02-28
Results Overview
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss \>1,000cc
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
333 participants
Primary outcome timeframe
30 days
Results posted on
2025-02-28
Participant Flow
Up to 180 subjects will be enrolled at a maximum of 30 sites in the EU, and US in the Primary Investigation. This includes up to 30 Roll-in subjects and up to 150 patients in the Intent to Treat Pivotal Cohort. At enrollment closure for the Primary Investigation, an Extended Investigation will commence at these sites to enroll up to 250 additional subjects under continued access provisions. The protocol allowed up to 430 total subjects, however, the actual enrollment total was 333.
Participant milestones
| Measure |
Pivotal Cohort (ITT)
The Intention to Treat Pivotal Cohort includes up to 150 subjects will be enrolled at a maximum of 30 sites in the US and the EU.This includes the statistically justified sample size of 132 plus an allowance for deviations from assumptions.
|
Roll-In Cohort
One (1) roll-in subject may be enrolled per site, therefore a maximum of 30 enrolled in the study, to allow for Investigator(s) to receive additional training on the Nellix System. Any roll-in subjects will be screened, consented, treated and followed identically to the main study cohort.However, the roll-in cohort of this study will be evaluated separately.
|
Continued Access Cohort
Up to 250 patients will be enrolled into the Extended Investigation based on an enrollment rate of 0.5 patients per site per month and an estimated 20 months from the close of enrollment in the Primary Investigation. Enrollment in Extended Investigation (continued access) phase will be limited to the 27 US sites only as the Nellix System is commercially available to the three participating European sites.
|
|---|---|---|---|
|
Overall Study
STARTED
|
150
|
29
|
154
|
|
Overall Study
COMPLETED
|
86
|
8
|
75
|
|
Overall Study
NOT COMPLETED
|
64
|
21
|
79
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
Baseline characteristics by cohort
| Measure |
Pivotal Cohort
n=150 Participants
Subject Demographics for the Pivotal cohort
|
Roll-In Cohort
n=29 Participants
Subject Demographics for the Roll-in cohort
|
Continued Access Cohort
n=154 Participants
Subject Demographics for the Continued Access cohort
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 8 • n=5 Participants
|
72 years
STANDARD_DEVIATION 10 • n=7 Participants
|
73 years
STANDARD_DEVIATION 7 • n=5 Participants
|
73 years
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
312 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
140 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
306 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Non-Caucasian
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysMajor Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss \>1,000cc
Outcome measures
| Measure |
Pivotal Cohort
n=150 Participants
Subject Demographics for the Pivotal cohort
|
Roll-In Cohort
n=29 Participants
Subject Demographics for the Roll-in cohort
|
Continued Access Cohort
n=154 Participants
Subject Demographics for the Continued Access cohort
|
|---|---|---|---|
|
Major Adverse Events at 30 Days
|
4 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1 yearProcedural 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.
Outcome measures
| Measure |
Pivotal Cohort
n=134 Participants
Subject Demographics for the Pivotal cohort
|
Roll-In Cohort
n=26 Participants
Subject Demographics for the Roll-in cohort
|
Continued Access Cohort
n=109 Participants
Subject Demographics for the Continued Access cohort
|
|---|---|---|---|
|
Treatment Success at 1 Year
|
126 Participants
|
22 Participants
|
94 Participants
|
Adverse Events
Pivotal Cohort (ITT)
Serious events: 26 serious events
Other events: 38 other events
Deaths: 1 deaths
Roll-In Cohort
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Continued Access Cohort
Serious events: 37 serious events
Other events: 40 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pivotal Cohort (ITT)
n=150 participants at risk
The Intention to Treat Pivotal Cohort includes up to 150 subjects will be enrolled at a maximum of 30 sites in the US and the EU.This includes the statistically justified sample size of 132 plus an allowance for deviations from assumptions.
|
Roll-In Cohort
n=29 participants at risk
One (1) roll-in subject may be enrolled per site, therefore a maximum of 30 enrolled in the study, to allow for Investigator(s) to receive additional training on the Nellix System. Any roll-in subjects will be screened, consented, treated and followed identically to the main study cohort.However, the roll-in cohort of this study will be evaluated separately.
|
Continued Access Cohort
n=154 participants at risk
Up to 250 patients will be enrolled into the Extended Investigation based on an enrollment rate of 0.5 patients per site per month and an estimated 20 months from the close of enrollment in the Primary Investigation. Enrollment in Extended Investigation (continued access) phase will be limited to the 27 US sites only as the Nellix System is commercially available to the three participating European sites.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Bleeding/Anemia
|
1.3%
2/150 • Number of events 2 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
3.4%
1/29 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
1.9%
3/154 • Number of events 4 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Gastrointestinal disorders
Bowel
|
1.3%
2/150 • Number of events 2 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.65%
1/154 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Cardiac disorders
Cardiac
|
4.7%
7/150 • Number of events 7 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
3.2%
5/154 • Number of events 5 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancies
|
2.7%
4/150 • Number of events 4 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/154 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
General disorders
Miscellaneous
|
1.3%
2/150 • Number of events 6 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
6.9%
2/29 • Number of events 2 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
2.6%
4/154 • Number of events 4 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Product Issues
Nellix Device
|
0.00%
0/150 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
6.5%
10/154 • Number of events 11 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Psychiatric disorders
Neurological
|
0.00%
0/150 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
1.3%
2/154 • Number of events 2 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
2.7%
4/150 • Number of events 5 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
2.6%
4/154 • Number of events 7 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Renal and urinary disorders
Renal
|
1.3%
2/150 • Number of events 3 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.65%
1/154 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Injury, poisoning and procedural complications
Surgical Site Wound
|
2.0%
3/150 • Number of events 3 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.65%
1/154 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Renal and urinary disorders
Urogenital
|
2.7%
4/150 • Number of events 4 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
3.4%
1/29 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
1.9%
3/154 • Number of events 3 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Vascular disorders
Vascular
|
3.3%
5/150 • Number of events 5 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
6.9%
2/29 • Number of events 2 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
9.1%
14/154 • Number of events 19 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
Other adverse events
| Measure |
Pivotal Cohort (ITT)
n=150 participants at risk
The Intention to Treat Pivotal Cohort includes up to 150 subjects will be enrolled at a maximum of 30 sites in the US and the EU.This includes the statistically justified sample size of 132 plus an allowance for deviations from assumptions.
|
Roll-In Cohort
n=29 participants at risk
One (1) roll-in subject may be enrolled per site, therefore a maximum of 30 enrolled in the study, to allow for Investigator(s) to receive additional training on the Nellix System. Any roll-in subjects will be screened, consented, treated and followed identically to the main study cohort.However, the roll-in cohort of this study will be evaluated separately.
|
Continued Access Cohort
n=154 participants at risk
Up to 250 patients will be enrolled into the Extended Investigation based on an enrollment rate of 0.5 patients per site per month and an estimated 20 months from the close of enrollment in the Primary Investigation. Enrollment in Extended Investigation (continued access) phase will be limited to the 27 US sites only as the Nellix System is commercially available to the three participating European sites.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Bleeding/Anemia
|
0.67%
1/150 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
1.3%
2/154 • Number of events 2 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Gastrointestinal disorders
Bowel
|
1.3%
2/150 • Number of events 2 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.65%
1/154 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Cardiac disorders
Cardiac
|
5.3%
8/150 • Number of events 8 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
3.4%
1/29 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.65%
1/154 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancies
|
0.00%
0/150 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/154 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
General disorders
Miscellaneous
|
7.3%
11/150 • Number of events 15 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
10.3%
3/29 • Number of events 3 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
10.4%
16/154 • Number of events 25 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Product Issues
Nellix Device
|
0.67%
1/150 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.65%
1/154 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Nervous system disorders
Neurological
|
3.3%
5/150 • Number of events 6 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
1.9%
3/154 • Number of events 3 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.67%
1/150 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
6.9%
2/29 • Number of events 2 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
3.9%
6/154 • Number of events 6 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Renal and urinary disorders
Renal
|
4.0%
6/150 • Number of events 7 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
1.3%
2/154 • Number of events 2 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Surgical and medical procedures
Surgical Site Wound
|
8.7%
13/150 • Number of events 15 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
3.4%
1/29 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
3.2%
5/154 • Number of events 5 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Renal and urinary disorders
Urogenital
|
2.7%
4/150 • Number of events 5 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
3.4%
1/29 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
3.2%
5/154 • Number of events 5 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Vascular disorders
Vascular
|
2.7%
4/150 • Number of events 4 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
6.5%
10/154 • Number of events 11 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
|
Skin and subcutaneous tissue disorders
Wound
|
0.67%
1/150 • Number of events 1 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/29 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
0.00%
0/154 • All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place