The Israeli MGuard Registry

March 5, 2014 updated by: InspireMD

A Prospective, Observational, Multicenter Registry To Evaluate the 'Real World' Clinical Performance of the MGuard Coronary Stent System

the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Prospective, Observational, Multicenter Registry The primary objective of this registry is to document the safety and overall clinical performance of the MGuard Coronary Stent System in a "real world" patient population requiring stent implantation.

The secondary objective is to assess the event rate in patient subgroups with specific clinical indications and/or vessel and/or lesion characteristics.

Study Type

Observational

Enrollment (Actual)

86

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
      • Natanya, Israel
        • Laniado Hospital
      • Zrifin, Israel
        • Asaf Harofe Medical Center

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 with an indication for coronary stent implantation according to the Israeli regulatory approval of the MGuard Coronary Stent System. All patients who receive one or more MGuard Coronary Stent System in one or more target lesions should be included.

Description

Inclusion Criteria:

  • Patient is > 18 years of age
  • The patient has consented to participate by signing the "Patient Informed Consent Form"
  • Patient is suitable for implantation of one or more MGuard Stent System in one or more target lesions
  • Target lesion(s) are according to the Indications for Use and Israeli regulatory approval of the MGuard Stent System
  • The patient is willing and able to cooperate with registry procedures and required follow up

Exclusion Criteria:

  • Heavily calcified target lesions
  • Target lesions with side branch bigger then 2.5mm
  • Target lesions which are distal to newly stented lesion (less than 1 month).
  • Women with known pregnancy
  • Current medical condition with a life expectancy of less than 12 months
  • Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits study participation

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MGuard
eligible patients implanted with minimum one MGuard stent
Device: MGuard Coronary Stent system
MGuard Coronary Stent system implanted within a PCI
Other Names:
  • MGuard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major Cardiac Adverse Events rate (MACE)
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding complications
Time Frame: 6 months
6 months
Major Cardiac Adverse Events rate (MACE)
Time Frame: 6 months
6 months
Lesion success rate
Time Frame: 1 day
1 day
Stent thrombosis rate
Time Frame: 6 months
6 months
Any death
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

InspireMD

Investigators

  • Study Director: Elad Yaacoby, InspireMD

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

July 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

March 6, 2014

Last Update Submitted That Met QC Criteria

March 5, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMD-05

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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