Stenosis
Conditions
Brief summary
The objective of this study is to collect data on the use of the WIRION system in Patients undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).
Detailed description
WIRION system is used as protection device in patients undergoing SVG stenting procedure. This retrospective study collects data on the usability of the WIRION during the procedure.
Interventions
DEVICESaphenous vein graft (SVG) stenting
Opening and stenting of blocked SVG with the use of the WIRION embolic protection filter
Sponsors
Gardia Medical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients underwent percutaneous intervention (PI) of SVG stenting in which the WIRIONTM system was used. * Patient is greater than or equal to 18 years of age.
Exclusion criteria
* Undergone cardiac surgery in the past 60 days before the procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure | 30 Days | Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days. |
| Number of Patients That Undergo Successful SVG Procedure | 30 Days | Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WIRION Patients undergoing SVG stenting procedure with the use of the WIRION | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | WIRION | — |
|---|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 8.8 | — |
| Diabetes | 10 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Israel | 12 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 12 |
| other Total, other adverse events | 4 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
Primary
Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure
Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days.
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WIRION | Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure | 5 Participants |
Primary
Number of Patients That Undergo Successful SVG Procedure
Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred.
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WIRION | Number of Patients That Undergo Successful SVG Procedure | 12 Participants |