The Israeli MGuard Registry

Completed

• Conditions: Ischemic Heart Disease; Acute Coronary Syndrome; Acute Myocardial Infarction
• Interventions: Device: MGuard Coronary Stent system

• Registration Number: NCT00922337
• Lead Sponsor: InspireMD

Brief Summary

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

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 Timeline

• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Study Start: 2009-07
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-05
• Last Update Posted: 2014-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MGuard	MGuard Coronary Stent system	eligible patients implanted with minimum one MGuard stent

Primary Outcome Measures

Name	Time	Method
Major Cardiac Adverse Events rate (MACE)	1 month

Secondary Outcome Measures

Name	Time	Method
Lesion success rate	1 day
Major Cardiac Adverse Events rate (MACE)	6 months
Bleeding complications	6 months
Stent thrombosis rate	6 months
Any death	6 months

Trial Locations

Locations (2)

Asaf Harofe Medical Center; 🇮🇱 Zrifin, Israel

Laniado Hospital; 🇮🇱 Natanya, Israel