The Israeli MGuard Registry

InspireMD86 enrolled

Overview

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

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

Conditions

Ischemic Heart Disease Acute Coronary Syndrome Acute Myocardial Infarction

Interventions

MGuard Coronary Stent systemDEVICE

MGuard Coronary Stent system implanted within a PCI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Laniado Hospital

Netanya, Israel

Asaf Harofe Medical Center

Zrifin, Israel

Outcomes

Primary Outcomes

Major Cardiac Adverse Events rate (MACE)

Time frame: 1 month

Secondary Outcomes

Major Cardiac Adverse Events rate (MACE)

Time frame: 6 months

Lesion success rate

Time frame: 1 day

Bleeding complications

Time frame: 6 months

Stent thrombosis rate

Time frame: 6 months

Any death

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.