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Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

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ClinicalTrials.gov Identifier: NCT00543270
Recruitment Status : Completed
First Posted : October 12, 2007
Last Update Posted : February 24, 2010
Information provided by:

Brief Summary:
Powerlink Bifurcated Infrarenal long-term follow-up study

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: Powerlink infrarenal bifurcated stent graft delivery system Procedure: Open Surgery Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 231 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endologix Powerlink Long-Term Follow-up Study
Study Start Date : October 2005
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
EVAR (Powerlink System)
Device: Powerlink infrarenal bifurcated stent graft delivery system
Endovascular abdominal aortic aneurysm repair
Other Name: Powerlink Stent Graft Delivery System
Active Comparator: B
Open Surgical Control
Procedure: Open Surgery
Open surgical abdominal aortic aneurysm repair

Primary Outcome Measures :
  1. Safety: Major adverse events. Effectiveness: Stent graft patency, aneurysm exclusion, aneurysm related mortality, and all-cause mortality. [ Time Frame: Through 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543270

United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
United States, California
Harbor-UCLA Medical Center
Torrance, California, United States, 90506
United States, Illinois
University of Illinois School of Medicine
Peoria, Illinois, United States, 61604
SIU School of Medicine
Springfield, Illinois, United States, 62702
United States, Iowa
Mercy Hospital
Des Moines, Iowa, United States, 50314
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New Jersey
Advanced Vascular Associates
Morristown, New Jersey, United States, 07960
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
University Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, South Dakota
Heart Hospital of South Dakota
Sioux Falls, South Dakota, United States, 57108
United States, Virginia
Vascular and Transplant Specialists
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Principal Investigator: Rodney White, MD University of California, Los Angeles