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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGuard | eligible patients implanted with minimum one MGuard stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGuard Coronary Stent system | Device | MGuard Coronary Stent system implanted within a PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Cardiac Adverse Events rate (MACE) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Major Cardiac Adverse Events rate (MACE) | 6 months | |
| Lesion success rate | 1 day | |
| Bleeding complications |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with an indication for coronary stent implantation according to the Israeli regulatory approval of the MGuard Coronary Stent System. All patients who receive one or more MGuard Coronary Stent System in one or more target lesions should be included.
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| Name | Affiliation | Role |
|---|---|---|
| Elad Yaacoby | InspireMD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laniado Hospital | Netanya | Israel | ||||
| Asaf Harofe Medical Center |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 6 months |
| Stent thrombosis rate | 6 months |
| Any death | 6 months |
| Zrifin |
| Israel |