Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

This study has been completed.
Sponsor:
Information provided by:
Endologix
ClinicalTrials.gov Identifier:
NCT00543270
First received: October 10, 2007
Last updated: February 22, 2010
Last verified: February 2010
  Purpose

Powerlink Bifurcated Infrarenal long-term follow-up study


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endologix Powerlink Long-Term Follow-up Study

Resource links provided by NLM:


Further study details as provided by Endologix:

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

Estimated Enrollment: 231
Study Start Date: October 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543270

Locations
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
Endologix
Investigators
Principal Investigator: Rodney White, MD University of California, Los Angeles
  More Information

Publications:
Responsible Party: Janet M. Fauls, VP, Regulatory and Clinical Affairs, Endologix, Inc.
ClinicalTrials.gov Identifier: NCT00543270     History of Changes
Other Study ID Numbers: TP00-005/CP04-001
Study First Received: October 10, 2007
Last Updated: February 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Endologix:
EVAR
AAA
Aneurysm
Powerlink

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on August 21, 2014