Study Stopped
Closed due to internal and external factors.
Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm
PAA 12-01
Retrospective Evaluation of the GORE® VIABAHN® Endoprosthesis for a Popliteal Artery Aneurysm Indication
Sponsor study identifier
observational
3
1 country
3
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 16, 2013
Actual (reported)July 18, 2013
Actual (reported)April 2014
Actual (reported)April 2014
Actual (reported)June 19, 2015
Actual (reported)Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.
A composite of freedom from failure of technical success or loss of primary patency at 12 months
12 months following initial study procedure
Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure.
30 day serious adverse events related to the initial study procedure or the study device.
30 days following initial study procedure
GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who had popliteam aneurysm and were treated with GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010.
Baptist Health
Miami, Florida, United States
The Vascular Group of Naples
Naples, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
Early termination of study. No subject analysis done
Hector Novoa, BS
W. L. Gore & Associates, Inc (sponsor)
3 participants (actual enrollment reported by the registry).
First Submitted
July 16, 2013
First Posted
July 18, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery
Contact the study team to confirm eligibility.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
June 19, 2015
Results First Posted
June 19, 2015
Record last verified: 2015-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: