The Israeli MGuard Registry

InspireMD

Status: Completed

Conditions: Ischemic Heart Disease; Acute Coronary Syndrome; Acute Myocardial Infarction

Treatments: Device: MGuard Coronary Stent system

Study type: Observational

Funder types: Industry

Identifiers

NCT00922337

IMD-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

86 participants in 1 patient group

MGuard

Description:

eligible patients implanted with minimum one MGuard stent

Treatment:

Device: MGuard Coronary Stent system