NCT02373852

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

September 12, 2019

Completed
Last Updated

September 12, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

September 22, 2014

Results QC Date

January 18, 2018

Last Update Submit

August 5, 2019

Conditions

Stenosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

Saphenous vein graft (SVG) stentingDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Undergone cardiac surgery in the past 60 days before the procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion

Haifa, Israel

Location

MeSH Terms

Conditions

Constriction, Pathologic

Interventions

Stents

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Results Point of Contact

Title
Dr Vardit Segal
Organization
Gardia Medical Ltd
vardit@gardiamedical.com
972-52-4579178

Study Officials

  • Vardit Segal, PhD

    Gardia medical manufacture the WIRION used in the study

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

February 27, 2015

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2016

Last Updated

September 12, 2019

Results First Posted

September 12, 2019

Record last verified: 2019-08

Locations

IL(1)