Powerlink infrarenal bifurcated stent graft delivery system
DeviceEndovascular abdominal aortic aneurysm repair
Other names: Powerlink Stent Graft Delivery System
Completed
NCT Number: NCT00543270
Powerlink Bifurcated Stent Graft Long-Term Follow-up Study
Endologix Infrarenal Bifurcated Stent Graft Study
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Arizona Heart Institute, Phoenix, Arizona, United States
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Open Surgery
ProcedureOpen surgical abdominal aortic aneurysm repair
Primary outcomes
-
No of Subjects with Major adverse events
Time frame: 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
Time frame: At 1 Year
No of deaths reported through 1 year
Secondary outcomes
-
Stent Graft Performance
Time frame: 30 Days
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
-
Stent Graft Performance
Time frame: 6 Months
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
-
Stent Graft Performance
Time frame: Year 1
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
-
Stent Graft Performance
Time frame: Year 2
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
-
Stent Graft Performance
Time frame: Year 3
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
-
Stent Graft Performance
Time frame: Year 4
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
-
Stent Graft Performance
Time frame: Year 5
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
-
Clinical Utility Outcomes
Time frame: During the Procedure
Estimated anesthesia time, fluoroscopy time, procedure time
-
Clinical Utility Outcomes
Time frame: During the Procedure
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.
-
Clinical Utility Outcomes
Time frame: up to 1 week
Estimated ICU time
-
Clinical Utility Outcomes
Time frame: up to 1 week
Estimated Hospitalization Time
-
Aneurysm Morphology
Time frame: 6 Months
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months
-
Aneurysm Morphology
Time frame: Year 1
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 1
-
Aneurysm Morphology
Time frame: Year 2
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 2
-
Aneurysm Morphology
Time frame: Year 3
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 3
-
Aneurysm Morphology
Time frame: Year 4
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 4
-
Aneurysm Morphology
Time frame: Year 5
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5
Sponsors and collaborators
Lead sponsor
Endologix
Industry
Registry information
Official study title
Endologix Powerlink Long-Term Follow-up Study
Important dates
- Study start
- 2005
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Oct 12, 2007
- Registry last updated
- Oct 5, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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