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

August 5, 2019 updated by: Gardia Medical

Post Marketing Surveillance (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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Bnai Zion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing percutaneous intervention (PI) of saphenous vein graft (SVG) stenting

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gardia Medical

Investigators

  • Study Director: Vardit Segal, PhD, Gardia medical manufacture the WIRION used in the study

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

February 22, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SVG-CL003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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