MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction (e-MASTER)

InspireMD

Status: Terminated

Conditions: ST Elevation Myocardial Infarction

Treatments: Device: MGuard™ Prime Embolic Protection Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT02292823

IMD-13

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.