PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention

Gardia Medical12 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Stenosis

Interventions

Saphenous vein graft (SVG) stentingDEVICE

Opening and stenting of blocked SVG with the use of the WIRION embolic protection filter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bnai Zion

Haifa, Israel

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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