ST Elevation Myocardial Infarction
Conditions
Keywords
STEMI, heart attack, stent, Bare Metal Stent, myocardial infarction, PCI
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.
Interventions
DEVICEMGuard™ Prime Embolic Protection Stent System
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
1. Subject is \>18 years of age. 2. Subject is experiencing clinical symptoms consistent with ST elevation acute myocardial infarction (STEMI) of \>30 minutes and \<24 hours. 3. Based on coronary anatomy, primary PCI is indicated for the culprit lesion with anticipated use of stenting. 4. Subject agrees to all required follow-up procedures and visits and has provided informed consent where required. 5. The target lesion is a de novo lesion in a native coronary artery. 6. The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment.
Exclusion criteria
1. Subject undergoing cardiopulmonary resuscitation. 2. 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). 3. 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. 4. Target lesion involves a bifurcation with a side branch \>/=2.0 mm in diameter. 5. In the Investigator's opinion the lesion/vessel is unsuitable for treatment with the MGuard™ Prime Embolic Protection Stent System for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete ST-segment resolution | 1 day |
| All cause death or MI at 30 days | 30 days |
Secondary
| Measure | 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 |
Countries
Netherlands
Outcome results
None listed