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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040002 / PAS001 |
| Date Original Protocol Accepted |
10/29/2004
|
| Date Current Protocol Accepted |
|
| Study Name |
Long Term/Pivotal Cohort
|
| Device Name |
ENDOLOGIX POWERLINK SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The post-approval study included all surviving endovascular patients from the original pivotal study cohort. There were no hypotheses was proposed to evaluate long-term (5-year) safety and effectiveness.
|
| Study Population |
The Endologix, Inc. Powerlink System is an endovascular stent graft and delivery system that is indicated for endovascular treatment of abdominal aortic aneurysms.
|
| Sample Size |
192 endovascular sten graft patients and 66 control patients across 15 sites
|
| Key Study Endpoints |
The primary effectiveness endpoint was all cause mortality. Primary safety endpoint was the incidence of major adverse events including: death, myocardial infarction, coronary intervention, respiratory failure, aneurysm rupture, kidney failure, secondary procedures, conversion to open surgical repair, stroke, blood loss, prosthesis migration, and patency.
|
| Follow-up Visits and Length of Follow-up |
Clinical follow-up and diagnostic test evaluations were scheduled pre-discharge, at one month, six months, one year and annually thereafter through five years.
|
| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
|
| Actual Number of Patients Enrolled |
192 endovascular stent graft patients and 66 control patients
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| Actual Number of Sites Enrolled |
15 sites
|
| Patient Follow-up Rate |
56% in the device group, 39% in the control group
|
| Final Safety Findings |
The overall implant success rate was 98% (188/192), with three patients requiring conversion to open surgical aneurysm repair. Of the 192 device patients, 108 (56.2%) patients were followed (107 had CT imaging follow-up), 43 (22.4%) patients had died, 4 (2.1%) had a conversion to open repair, and 37 (19.3%) withdrew or were lost to follow-up at 5 years. Of the 66 surgical controls 26 (39.4%) patients were followed, 15 (22.7%) patients had died, and 25 (38.9%) withdrew or were lost to follow-up at 5 years. There were four reported aneurysm related deaths in the device group. There were no deaths due to aneurysm rupture. The deaths occurred at 1-day, 9-days, 33-days, and 403-days. The late death occurred during a conversion to open repair. There does not appear to be a problem with a late failure rate in the device.
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| Study Strengths & Weaknesses |
Weakness: Higher proportion of patients wtithdrew or were lost to follow-up in control group (39%) Therere 19% of patients who withdrew or were lost to follow-up in the device group.
|
| Recommendations for Labeling Changes |
None
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