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

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).

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Key information

Conditions

Stenosis Constriction, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bnai Zion

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saphenous vein graft (SVG) stenting

Device

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

Primary outcomes

Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure

Time frame: 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

Time frame: 30 Days

Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred.

Sponsors and collaborators

Lead sponsor

Gardia Medical

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Feb 27, 2015
Registry last updated: Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed