GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms
A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
1 other identifier
interventional
139
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2005
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
August 23, 2010
CompletedJanuary 8, 2018
December 1, 2017
3.7 years
December 20, 2007
April 20, 2010
December 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure
2 years
Secondary Outcomes (1)
Number of Subjects With Device Efficacy Events
2 years
Interventions
Eligibility Criteria
You may qualify if:
- Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
- Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
- Access vessel able to receive 18 French introducer sheath
- Life expectancy \> 2 years
- Appropriate candidate for endovascular repair
- Ability to comply with protocol requirements including follow-up
- years of age or older, male or infertile female\*\*
You may not qualify if:
- Mycotic or ruptured aneurysm
- Participating in another investigational device or drug study within one year
- Documented history of drug abuse within six months
- Myocardial infarction or cerebral vascular accident within six weeks
- Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
- Iliac anatomy that would require occlusion of both internal iliac arteries
- Planned occlusion or reimplantation of significant mesenteric or renal arteries
- Planned concomitant surgical procedure or previous major surgery within 30 days
- Previous prosthesis placement in the aorta or iliac arteries
- Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tab Bonny
- Organization
- W.L. Gore and Associates
Study Officials
- PRINCIPAL INVESTIGATOR
Mark F Fillinger, MD
Dartmouth-Hitchcock Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 20, 2007
First Posted
January 15, 2008
Study Start
June 1, 2005
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
January 8, 2018
Results First Posted
August 23, 2010
Record last verified: 2017-12