Aortic Aneurysm, Abdominal
Conditions
Brief summary
The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.
Interventions
DEVICEGORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
Implant
Sponsors
W.L.Gore & Associates
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
1. Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter 2. Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use 3. Access vessel able to receive 18 French introducer sheath 4. Life expectancy \> 2 years 5. Appropriate candidate for endovascular repair 6. Ability to comply with protocol requirements including follow-up 7. 21 years of age or older, male or infertile female\*\*
Exclusion criteria
1. Mycotic or ruptured aneurysm 2. Participating in another investigational device or drug study within one year 3. Documented history of drug abuse within six months 4. Myocardial infarction or cerebral vascular accident within six weeks 5. Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function 6. Iliac anatomy that would require occlusion of both internal iliac arteries 7. Planned occlusion or reimplantation of significant mesenteric or renal arteries 8. Planned concomitant surgical procedure or previous major surgery within 30 days 9. Previous prosthesis placement in the aorta or iliac arteries 10. Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of Subjects With Device Efficacy Events | 2 years |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EXCLUDER Low Permeability Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft. | 139 |
| Original EXCLUDER Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms. | 120 |
| Total | 259 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 7 | 0 |
| Overall Study | Lost to Follow-up | 7 | 0 |
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 0 |
Baseline characteristics
| Characteristic | EXCLUDER Low Permeability | Original EXCLUDER | Total |
|---|---|---|---|
| Age, Continuous | 73.9 years STANDARD_DEVIATION 7.5 | 72.6 years STANDARD_DEVIATION 7.7 | 73.3 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment United States | 139 participants | 120 participants | 259 participants |
| Sex: Female, Male Female | 27 Participants | 14 Participants | 41 Participants |
| Sex: Female, Male Male | 112 Participants | 106 Participants | 218 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 85 / 139 | 56 / 120 |
| serious Total, serious adverse events | 0 / 139 | 0 / 120 |
Outcome results
Primary
Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EXCLUDER Low Permeability | Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure | 9 participants |
| Original EXCLUDER | Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure | 31 participants |
p-value: <0.001Chi-squared
Secondary
Number of Subjects With Device Efficacy Events
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EXCLUDER Low Permeability | Number of Subjects With Device Efficacy Events | 14 Participants |
| Original EXCLUDER | Number of Subjects With Device Efficacy Events | 19 Participants |