MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Prospective, non-randomized, single arm, multicenter observational study. The objective is to evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) in a real-world setting.

Official Title
-----------------
e-MASTER Registry: MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction

Conditions
-----------------
ST Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Device: MGuard™ Prime Embolic Protection Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is >18 years of age. Subject is experiencing clinical symptoms consistent with ST elevation acute myocardial infarction (STEMI) of >30 minutes and <24 hours. Based on coronary anatomy, primary PCI is indicated for the culprit lesion with anticipated use of stenting. Subject agrees to all required follow-up procedures and visits and has provided informed consent where required. The target lesion is a de novo lesion in a native coronary artery. The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment. Exclusion Criteria: Subject undergoing cardiopulmonary resuscitation. Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or intra-aortic balloon bump (IABP) or other hemodynamic support device for hypotension). Co-morbid condition(s) or others that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial. Target lesion involves a bifurcation with a side branch >/=2.0 mm in diameter. In the Investigator's opinion the lesion/vessel is unsuitable for treatment with the MGuard™ Prime Embolic Protection Stent System for any reason.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MGuard™ Prime Embolic Protection Stent System|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete ST-segment resolution |  | 1 day | 
| All cause death or MI at 30 days |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIMI flow grade |  | 1 day | 
| Major Adverse Cardiac Events rate (MACE): cardiac death, re-MI, clinically-driven target lesion revascularization (TLR) |  | Discharge, 30 days, 6 months, 12 months | 
| Acute success rates |  | 1 day | 
| Stent thrombosis rate |  | Discharge, 30 days, 6 months,12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCI, STEMI, heart attack, stent, Bare Metal Stent, myocardial infarction