Abdominal Aortic Aneurysm
Conditions
Keywords
AAA, Aneurysm, Suprarenal, Proximal, Cuff, Extension, Endograft, Endovascular repair, EVAR, Endoleak, Type I
Brief summary
The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
Interventions
DEVICESuprarenal Proximal Cuff Extension
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
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
* 18 years old * Informed consent understood and signed * Will comply with post-treatment follow-up requirements up to 5 years * Candidate for Powerlink Infrarenal Bifurcated Graft
Exclusion criteria
* Life expectancy \< 2 years * Participating in another clinical research study * Pregnant or lactating women * Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study * Creatinine level \> 1.7mg/dl * Renal transplant patient * Patient with \> 75% renal artery stenosis and not eligible for PTA/stent intervention prior to suprarenal device fixation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Proximal Type I Endoleak | Within 30 Days | The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Major Adverse Events | Within 30 days | All cause death, AAA rupture, Conversion / Explant, Coronary Intervention, Myocardial Infarction, Renal Failure, Respiratory Failure, Secondary Procedure, Stroke |
| Number of Participants With Stent Graft Integrity and Performance | 30 days | Number of Participants with Stent Fracture, Stent Graft Obstruction, Loss of device Integrity and Stent Migration - Core Lab reported Stent Graft Integrity Evaluation Results |
| Endoleak | 30 days | Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak. Endoleak diagnosis results as reported by the Core Lab. |
| Aneurysm Morphology Changes | 30 days | Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab. |
| Renal Function | 30 days | Renal function as measured by serum creatinine. Laboratory results, |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suprarenal Proximal Cuff Extension Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.
Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | patients were not due for the 2 year follow-up | 34 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Suprarenal Proximal Cuff Extension |
|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 10.1 |
| Ankle-Brachial Index(ABI) Ankle-brachial index (ABI) - left | 1.01 ratio STANDARD_DEVIATION 0.2 |
| Ankle-Brachial Index(ABI) Ankle-brachial index (ABI) - Right | 1.0 ratio STANDARD_DEVIATION 0.17 |
| Body Mass Index (BMI) | 28 kg/m^2 STANDARD_DEVIATION 5.5 |
| Race/Ethnicity, Customized Race Non-White | 7 Participants |
| Race/Ethnicity, Customized Race White | 37 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 44 |
| other Total, other adverse events | 12 / 44 |
| serious Total, serious adverse events | 11 / 44 |
Outcome results
Primary
Number of Subjects With Proximal Type I Endoleak
The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment.
Time frame: Within 30 Days
Population: Out of the 44 subjects enrolled 2 subjects withdrew even before reaching the 30day follow-up visit mark. Thus, 42 subjects were analyzed for the primary outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suprarenal Proximal Cuff Extension | Number of Subjects With Proximal Type I Endoleak | 2 Participants |
Secondary
Aneurysm Morphology Changes
Aneurysm morphology changes (Volume) as reported by CoreLab.
Time frame: 30 days
Population: All available data for 30 days has been reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suprarenal Proximal Cuff Extension | Aneurysm Morphology Changes | 170 cubic cm(cm^3) | Standard Deviation 56 |
Secondary
Aneurysm Morphology Changes
Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab.
Time frame: 30 days
Population: All available data for 30 days has been reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suprarenal Proximal Cuff Extension | Aneurysm Morphology Changes | 54 mm | Standard Deviation 8.7 |
Secondary
Endoleak
Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak. Endoleak diagnosis results as reported by the Core Lab.
Time frame: 30 days
Population: All available data at 30 days is reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Suprarenal Proximal Cuff Extension | Endoleak | Type I (Attachment site) | 2 Participants |
| Suprarenal Proximal Cuff Extension | Endoleak | Type II (Collateral) | 6 Participants |
| Suprarenal Proximal Cuff Extension | Endoleak | Indeterminant | 1 Participants |
Secondary
Number of Participants With Stent Graft Integrity and Performance
Number of Participants with Stent Fracture, Stent Graft Obstruction, Loss of device Integrity and Stent Migration - Core Lab reported Stent Graft Integrity Evaluation Results
Time frame: 30 days
Population: All available data has been reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Suprarenal Proximal Cuff Extension | Number of Participants With Stent Graft Integrity and Performance | Stent Fracture | 0 Participants |
| Suprarenal Proximal Cuff Extension | Number of Participants With Stent Graft Integrity and Performance | Stent Graft Obstruction | 0 Participants |
| Suprarenal Proximal Cuff Extension | Number of Participants With Stent Graft Integrity and Performance | Loss of Device Integrity | 0 Participants |
| Suprarenal Proximal Cuff Extension | Number of Participants With Stent Graft Integrity and Performance | Stent Graft Migration | 0 Participants |
Secondary
Number of Subjects With Major Adverse Events
All cause death, AAA rupture, Conversion / Explant, Coronary Intervention, Myocardial Infarction, Renal Failure, Respiratory Failure, Secondary Procedure, Stroke
Time frame: Within 30 days
Population: All available data has been reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Suprarenal Proximal Cuff Extension | Number of Subjects With Major Adverse Events | All-Cause Death | 0 Participants |
| Suprarenal Proximal Cuff Extension | Number of Subjects With Major Adverse Events | AAA rupture | 0 Participants |
| Suprarenal Proximal Cuff Extension | Number of Subjects With Major Adverse Events | Conversion / Explant | 0 Participants |
| Suprarenal Proximal Cuff Extension | Number of Subjects With Major Adverse Events | Coronary Intervention | 0 Participants |
| Suprarenal Proximal Cuff Extension | Number of Subjects With Major Adverse Events | Myocardial Infarction | 0 Participants |
| Suprarenal Proximal Cuff Extension | Number of Subjects With Major Adverse Events | Renal Failure | 1 Participants |
| Suprarenal Proximal Cuff Extension | Number of Subjects With Major Adverse Events | Respiratory Failure | 1 Participants |
| Suprarenal Proximal Cuff Extension | Number of Subjects With Major Adverse Events | Secondary Procedure | 0 Participants |
| Suprarenal Proximal Cuff Extension | Number of Subjects With Major Adverse Events | Stroke | 0 Participants |
Secondary
Renal Function
Renal function as measured by serum creatinine. Laboratory results,
Time frame: 30 days
Population: All available 30 day data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suprarenal Proximal Cuff Extension | Renal Function | 1.08 mg/dL | Standard Deviation 0.35 |