Abdominal Aortic Aneurysm
Conditions
Keywords
EVAR, AAA, Aneurysm, Powerlink
Brief summary
Endologix Infrarenal Bifurcated Stent Graft Study
Interventions
DEVICEPowerlink infrarenal bifurcated stent graft delivery system
Endovascular abdominal aortic aneurysm repair
PROCEDUREOpen Surgery
Open surgical abdominal aortic aneurysm repair
Sponsors
Endologix
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All surviving patients from the original study cohort who received the Powerlink device * All surviving patients from the original study cohort who were assigned to the open surgical control arm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No of Subjects with Major adverse events | At 1 Year | Aneurysm-related mortality, aneurysm rupture, conversion to open repair, coronary intervention, myocardial infarction, renal failure, respiratory failure, secondary procedure, and stroke |
| All Cause Mortality | At 1 Year | No of deaths reported through 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent Graft Performance | 30 Days | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration |
| Clinical Utility Outcomes | During the Procedure | Estimated anesthesia time, fluoroscopy time, procedure time |
| Aneurysm Morphology | 6 Months | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months |
Countries
United States
Outcome results
None listed