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Completed

NCT Number: NCT00922337

The Israeli MGuard Registry

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laniado Hospital, Netanya, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MGuard Coronary Stent system

Device

MGuard Coronary Stent system implanted within a PCI

Other names: MGuard

Primary outcomes

  1. Major Cardiac Adverse Events rate (MACE)

    Time frame: 1 month

Secondary outcomes

  1. Major Cardiac Adverse Events rate (MACE)

    Time frame: 6 months

  2. Lesion success rate

    Time frame: 1 day

  3. Bleeding complications

    Time frame: 6 months

  4. Stent thrombosis rate

    Time frame: 6 months

  5. Any death

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

InspireMD

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 17, 2009
Registry last updated
Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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