PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention
Completed
- Conditions
- Stenosis
- Registration Number
- NCT02373852
- Lead Sponsor
- Gardia Medical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bnai Zion
🇮🇱Haifa, Israel