Abdominal Aortic Aneurysm (AAA)
Conditions
Keywords
Infrarenal, Abdominal, Aortic, Aneurysm, AAA, Endologix, EVAS, EndoVascular, Sealing, System
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.
Interventions
DEVICENellix System
Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.
Sponsors
Endologix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany, Netherlands, United Kingdom, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Pivotal Cohort Subject Demographics for the Pivotal cohort | 150 |
| Roll-In Cohort Subject Demographics for the Roll-in cohort | 29 |
| Continued Access Cohort Subject Demographics for the Continued Access cohort | 154 |
| Total | 333 |
Baseline characteristics
| Characteristic | Pivotal Cohort | Roll-In Cohort | Continued Access Cohort | Total |
|---|---|---|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 8 | 72 years STANDARD_DEVIATION 10 | 73 years STANDARD_DEVIATION 7 | 73 years STANDARD_DEVIATION 8 |
| Race/Ethnicity, Customized Race Caucasian | 140 Participants | 25 Participants | 141 Participants | 306 Participants |
| Race/Ethnicity, Customized Race Non-Caucasian | 10 Participants | 4 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Female | 8 Participants | 0 Participants | 13 Participants | 21 Participants |
| Sex: Female, Male Male | 142 Participants | 29 Participants | 141 Participants | 312 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 150 | 0 / 29 | 1 / 154 |
| other Total, other adverse events | 38 / 150 | 7 / 29 | 40 / 154 |
| serious Total, serious adverse events | 26 / 150 | 5 / 29 | 37 / 154 |
Outcome results
Primary
Major Adverse Events at 30 Days
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss \>1,000cc
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pivotal Cohort | Major Adverse Events at 30 Days | 4 Participants |
| Roll-In Cohort | Major Adverse Events at 30 Days | 1 Participants |
| Continued Access Cohort | Major Adverse Events at 30 Days | 2 Participants |
Primary
Treatment Success at 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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pivotal Cohort | Treatment Success at 1 Year | 126 Participants |
| Roll-In Cohort | Treatment Success at 1 Year | 22 Participants |
| Continued Access Cohort | Treatment Success at 1 Year | 94 Participants |