Aortic Aneurysm, Abdominal
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms
Detailed description
The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms.
Interventions
DEVICE31 mm GORE EXCLUDER® AAA Endoprosthesis
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Infrarenal AAA \> or equal to 4.5 cm in diameter * Proximal infrarenal aortic neck length \> or equal 15mm * Anatomy meets 31mm EXCLUDER specification criteria * Access vessel able to receive 20 Fr. introducer sheath * Life expectancy \>2 years * Surgical candidate * ASA Class I, II, III, or IV * NYHA Class I, II, III * 21 years of age or older * Male or infertile female * Ability to comply with protocol requirements including follow-up * Signed Informed Consent Form
Exclusion criteria
* Mycotic or ruptured aneurysm * Participating in another investigational device or drug study within 1 year * Documented history of drug abuse within 6 months * Coexisting thoracic aortic aneurysm (50% larger than proximal aorta) * Myocardial infarction or cerebral vascular accident within 6 weeks * Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function * Renal insufficiency (Creatinine \> 2.5 mg/dL) without dialysis * Iliac anatomy that would require occlusion of both internal iliac arteries * Planned occlusion or reimplantation of significant mesenteric or renal arteries * Planned concomitant surgical procedure or previous major surgery within 30 days * Previous prosthesis placement in the same position of the aorta or iliac arteries * Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome * Proximal neck angulation \> 60 degrees * Presence of significant thrombus at arterial implantation sites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year | Treatment through 1 year post-procedure (365 days) |
Secondary
| Measure | Time frame |
|---|---|
| Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications | Treatment through 1 year window post-procedure (through end of 1 year window, 546 days) |
Countries
United States
Participant flow
Recruitment details
Recruitment: May 2006 - Mar 2009 (Study Subjects and Continued Access)
Participants by arm
| Arm | Count |
|---|---|
| 31 mm GORE EXCLUDER® Test Subjects GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 10 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | 31 mm GORE EXCLUDER® Test Subjects |
|---|---|
| Age, Continuous | 73.9 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 33 / 35 |
| serious Total, serious adverse events | 24 / 35 |
Outcome results
Primary
Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year
Time frame: Treatment through 1 year post-procedure (365 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 31 mm GORE EXCLUDER® Test Subjects | Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year | 84.0 days | Standard Error 24.2 |
Comparison: Log-rank test of freedom from major adverse events through 1 year, 31 mm GORE EXCLUDER® Test Subjects vs historical open surgical control Subjects.p-value: 0.003Log Rank
Secondary
Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications
Time frame: Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 31 mm GORE EXCLUDER® Test Subjects | Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications | 4 Participants |
Comparison: Estimation of Hazard ratio of the 31 mm GORE EXCLUDER® Test Subjects vs original GORE EXCLUDER® AAA Endoprosthesis Subjects (original PMA subjects) using Cox Regression, not a powered analysis.95% CI: [0.428, 3.603]