Trial Outcomes & Findings for PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention (NCT NCT02373852)
NCT ID: NCT02373852
Last Updated: 2019-09-12
Results Overview
Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days.
Recruitment status
COMPLETED
Target enrollment
12 participants
Primary outcome timeframe
30 Days
Results posted on
2019-09-12
Participant Flow
Participant milestones
| Measure |
WIRION
Patients undergoing SVG stenting procedure with the use of the WIRION
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
WIRION
n=12 Participants
Patients undergoing SVG stenting procedure with the use of the WIRION
|
|---|---|
|
Age, Continuous
|
71.7 years
STANDARD_DEVIATION 8.8 • n=12 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=12 Participants
|
|
Region of Enrollment
Israel
|
12 participants
n=12 Participants
|
|
Diabetes
|
10 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 30 DaysCollect and analyse all adverse events occurred during and following the SVG procedure up to 30 days.
Outcome measures
| Measure |
WIRION
n=12 Participants
Patients undergoing SVG stenting procedure with the use of the WIRION
|
|---|---|
|
Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure
|
5 Participants
|
PRIMARY outcome
Timeframe: 30 DaysSuccessful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred.
Outcome measures
| Measure |
WIRION
n=12 Participants
Patients undergoing SVG stenting procedure with the use of the WIRION
|
|---|---|
|
Number of Patients That Undergo Successful SVG Procedure
|
12 Participants
|
Adverse Events
WIRION
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
WIRION
n=12 participants at risk
Patients undergoing SVG stenting procedure with the use of the WIRION
|
|---|---|
|
Cardiac disorders
Death
|
8.3%
1/12
|
Other adverse events
| Measure |
WIRION
n=12 participants at risk
Patients undergoing SVG stenting procedure with the use of the WIRION
|
|---|---|
|
Cardiac disorders
Chest pain on effort
|
33.3%
4/12 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place