Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

Study Overview
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Brief Summary
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Endologix Infrarenal Bifurcated Stent Graft Study

Official Title
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Endologix Powerlink Long-Term Follow-up Study

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Powerlink infrarenal bifurcated stent graft delivery system
* Procedure: Open Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular Repair - EVAR (Powerlink System)<br>EVAR (Powerlink System) | Device: Powerlink infrarenal bifurcated stent graft delivery system<br>* Endovascular abdominal aortic aneurysm repair<br>* Other names: Powerlink Stent Graft Delivery System;|
| Active Comparator: Open Surgical Control<br>Open Surgical Control | Procedure: Open Surgery<br>* Open surgical abdominal aortic aneurysm repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No of Subjects with Major adverse events | Aneurysm-related mortality, aneurysm rupture, conversion to open repair, coronary intervention, myocardial infarction, renal failure, respiratory failure, secondary procedure, and stroke | At 1 Year | 
| All Cause Mortality | No of deaths reported through 1 year | At 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | 30 Days | 
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | 6 Months | 
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | Year 1 | 
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | Year 2 | 
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | Year 3 | 
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | Year 4 | 
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | Year 5 | 
| Clinical Utility Outcomes | Estimated anesthesia time, fluoroscopy time, procedure time | During the Procedure | 
| Clinical Utility Outcomes | Estimated blood loss (ml) and contrast volume (ml). Estimated blood loss records the approximate amount of blood that the patient lost during the surgery (ml) and contract volume is the volume of the contrast (ml) calculated during the procedure. | During the Procedure | 
| Clinical Utility Outcomes | Estimated ICU time | up to 1 week | 
| Clinical Utility Outcomes | Estimated Hospitalization Time | up to 1 week | 
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months | 6 Months | 
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 1 | Year 1 | 
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 2 | Year 2 | 
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 3 | Year 3 | 
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 4 | Year 4 | 
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5 | Year 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EVAR, AAA, Aneurysm, Powerlink