Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saphenous vein graft (SVG) stenting | Device | Opening and stenting of blocked SVG with the use of the WIRION embolic protection filter |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 Days |
| 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. | 30 Days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
patients undergoing percutaneous intervention (PI) of saphenous vein graft (SVG) stenting
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vardit Segal, PhD | Gardia medical manufacture the WIRION used in the study | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion | Haifa | Israel |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | WIRION | Patients undergoing SVG stenting procedure with the use of the WIRION |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | WIRION | Patients undergoing SVG stenting procedure with the use of the WIRION |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 30 Days |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WIRION | Patients undergoing SVG stenting procedure with the use of the WIRION |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Cardiogenic shock |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain on effort | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Vardit Segal | Gardia Medical Ltd | 972-52-4579178 | vardit@gardiamedical.com |
Not provided
| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes | Count of Participants | 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. | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| 1 |
| 12 |
| 1 |
| 12 |
| 4 |
| 12 |
Not provided
Not provided