Trial Outcomes & Findings for Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm (NCT NCT01902888)
NCT ID: NCT01902888
Last Updated: 2015-06-19
Results Overview
A composite of freedom from failure of technical success or loss of primary patency at 12 months
Recruitment status
TERMINATED
Target enrollment
3 participants
Primary outcome timeframe
12 months following initial study procedure
Results posted on
2015-06-19
Participant Flow
Participant milestones
| Measure |
Popliteal Aneurysm
GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
GORE® VIABAHN® Endoprosthesis
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Popliteal Aneurysm
GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
GORE® VIABAHN® Endoprosthesis
|
|---|---|
|
Overall Study
Study Terminated
|
3
|
Baseline Characteristics
Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm
Baseline characteristics by cohort
| Measure |
Popliteal Aneurysm
n=3 Participants
GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
GORE® VIABAHN® Endoprosthesis
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 12.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months following initial study procedureA composite of freedom from failure of technical success or loss of primary patency at 12 months
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 days following initial study procedure30 day serious adverse events related to the initial study procedure or the study device.
Outcome measures
Outcome data not reported
Adverse Events
Popliteal Aneurysm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Arthur Scott / Clinical Study Manager
W.L. Gore and Associates, Inc.
Phone: 623.208.3365
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place