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

Terminated

• Conditions: ST Elevation Myocardial Infarction

• Registration Number: NCT02292823
• Lead Sponsor: InspireMD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-17
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Primary Completion: 2015-09
• Last Update Posted: 2015-09-02
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete ST-segment resolution	1 day
All cause death or MI at 30 days	30 days

Secondary Outcome Measures

Name	Time	Method
TIMI flow grade	1 day
Stent thrombosis rate	Discharge, 30 days, 6 months,12 months
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

Trial Locations

Locations (1)

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands