Clinical trial NCT02292823: MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction
Official title: e-MASTER Registry: MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: ST Elevation Myocardial Infarction
Keywords: STEMI
heart attack
stent
Bare Metal Stent
myocardial infarction
PCI
Lead sponsor: InspireMD
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing primary revascularization for STEMI and who are intended to undergo primary PCI with the MGuard™ Prime Embolic Protection Stent System.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Complete ST-segment resolution
timeFrame: 1 day
measure: All cause death or MI at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: TIMI flow grade
timeFrame: 1 day
measure: Major Adverse Cardiac Events rate (MACE): cardiac death, re-MI, clinically-driven target lesion revascularization (TLR)
timeFrame: Discharge, 30 days, 6 months, 12 months
measure: Acute success rates
timeFrame: 1 day
measure: Stent thrombosis rate
timeFrame: Discharge, 30 days, 6 months,12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
Study officials:
References: