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

NCT ID: NCT02373852

Last Updated: 2019-09-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Saphenous vein graft (SVG) stenting

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gardia Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vardit Segal, PhD

Role: STUDY_DIRECTOR

Gardia medical manufacture the WIRION used in the study

Locations

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Bnai Zion

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SVG-CL003

Identifier Type: -

Identifier Source: org_study_id

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