Acute Coronary Syndrome, Acute Myocardial Infarction, Ischemic Heart Disease
Conditions
Keywords
distal embolization, thrombotic lesions, AMI, ACS, SVG
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.
Interventions
DEVICEMGuard Coronary Stent system
MGuard Coronary Stent system implanted within a PCI
Sponsors
InspireMD
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Cardiac Adverse Events rate (MACE) | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Major Cardiac Adverse Events rate (MACE) | 6 months |
| Lesion success rate | 1 day |
| Bleeding complications | 6 months |
| Stent thrombosis rate | 6 months |
| Any death | 6 months |
Countries
Israel
Outcome results
None listed