- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00543270
Powerlink Bifurcated Stent Graft Long-Term Follow-up Study
September 30, 2021 updated by: Endologix
Endologix Powerlink Long-Term Follow-up Study
Endologix Infrarenal Bifurcated Stent Graft Study
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
258
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85006
- Arizona Heart Institute
-
-
California
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Torrance, California, United States, 90506
- Harbor-UCLA Medical Center
-
-
Illinois
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Peoria, Illinois, United States, 61604
- University of Illinois School of Medicine
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Springfield, Illinois, United States, 62702
- SIU School of Medicine
-
-
Iowa
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Des Moines, Iowa, United States, 50314
- Mercy Hospital
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Missouri
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Saint Louis, Missouri, United States, 63110
- Barnes Jewish Hospital
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-
New Jersey
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Morristown, New Jersey, United States, 07960
- Advanced Vascular Associates
-
-
Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Oklahoma Cardiovascular Research Group
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University Hospital of Pennsylvania
-
-
South Carolina
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Greenville, South Carolina, United States, 29605
- Greenville Hospital System
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-
South Dakota
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Sioux Falls, South Dakota, United States, 57108
- Heart Hospital of South Dakota
-
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Virginia
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Norfolk, Virginia, United States, 23510
- Vascular and Transplant Specialists
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endovascular Repair - EVAR (Powerlink System)
EVAR (Powerlink System)
|
Endovascular abdominal aortic aneurysm repair
Other Names:
|
Active Comparator: Open Surgical Control
|
Open surgical abdominal aortic aneurysm repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At 1 Year
|
All Cause Mortality
Time Frame: At 1 Year
|
No of deaths reported through 1 year
|
At 1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stent Graft Performance
Time Frame: 30 Days
|
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
|
30 Days
|
Stent Graft Performance
Time Frame: 6 Months
|
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
|
6 Months
|
Stent Graft Performance
Time Frame: Year 1
|
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
|
Year 1
|
Stent Graft Performance
Time Frame: Year 2
|
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
|
Year 2
|
Stent Graft Performance
Time Frame: Year 3
|
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
|
Year 3
|
Stent Graft Performance
Time Frame: Year 4
|
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
|
Year 4
|
Stent Graft Performance
Time Frame: Year 5
|
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
|
Year 5
|
Clinical Utility Outcomes
Time Frame: During the Procedure
|
Estimated anesthesia time, fluoroscopy time, procedure time
|
During the Procedure
|
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.
|
During the Procedure
|
Clinical Utility Outcomes
Time Frame: up to 1 week
|
Estimated ICU time
|
up to 1 week
|
Clinical Utility Outcomes
Time Frame: up to 1 week
|
Estimated Hospitalization Time
|
up to 1 week
|
Aneurysm Morphology
Time Frame: 6 Months
|
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months
|
6 Months
|
Aneurysm Morphology
Time Frame: Year 1
|
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 1
|
Year 1
|
Aneurysm Morphology
Time Frame: Year 2
|
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 2
|
Year 2
|
Aneurysm Morphology
Time Frame: Year 3
|
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 3
|
Year 3
|
Aneurysm Morphology
Time Frame: Year 4
|
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 4
|
Year 4
|
Aneurysm Morphology
Time Frame: Year 5
|
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5
|
Year 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rodney White, MD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Carpenter JP. The Powerlink bifurcated system for endovascular aortic aneurysm repair: four-year results of the US multicenter trial. J Cardiovasc Surg (Torino). 2006 Jun;47(3):239-43.
- Parmer SS, Carpenter JP; Endologix Investigators. Endovascular aneurysm repair with suprarenal vs infrarenal fixation: a study of renal effects. J Vasc Surg. 2006 Jan;43(1):19-25. doi: 10.1016/j.jvs.2005.09.025.
- Wang GJ, Carpenter JP. EVAR in small versus large aneurysms: does size influence outcome? Vasc Endovascular Surg. 2009 Jun-Jul;43(3):244-51. doi: 10.1177/1538574408327570. Epub 2008 Dec 16.
- Wang GJ, Carpenter JP; Endologix Investigators. The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. J Vasc Surg. 2008 Sep;48(3):535-45. doi: 10.1016/j.jvs.2008.04.031. Epub 2008 Jul 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
October 10, 2007
First Submitted That Met QC Criteria
October 11, 2007
First Posted (Estimate)
October 12, 2007
Study Record Updates
Last Update Posted (Actual)
October 5, 2021
Last Update Submitted That Met QC Criteria
September 30, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TP00-005/CP04-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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