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NCT02373852 Clinical Trial

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

Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02373852
Other study ID # SVG-CL003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date June 2016

Study information
Verified date August 2019
Source Gardia Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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 information / eligibility
Status Completed
Enrollment 12
Est. completion date June 2016
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Saphenous vein graft (SVG) stenting
Opening and stenting of blocked SVG with the use of the WIRION embolic protection filter

Locations
Country Name City State
Israel Bnai Zion Haifa

Sponsors (1)
Lead Sponsor Collaborator
Gardia Medical

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
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. 30 Days
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. 30 Days
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