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

ST Elevation Myocardial Infarction Clinical Trial

— e-MASTER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02292823
• Other study ID #: IMD-13
• Status: Terminated
• Phase: N/A
• First received: November 13, 2014
• Last updated: August 31, 2015
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2015
• Source: InspireMD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Device:
• MGuard™ Prime Embolic Protection Stent System

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
InspireMD

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete ST-segment resolution		1 day	No
Primary	All cause death or MI at 30 days		30 days	Yes
Secondary	TIMI flow grade		1 day	No
Secondary	Major Adverse Cardiac Events rate (MACE): cardiac death, re-MI, clinically-driven target lesion revascularization (TLR)		Discharge, 30 days, 6 months, 12 months	Yes
Secondary	Acute success rates		1 day	No
Secondary	Stent thrombosis rate		Discharge, 30 days, 6 months,12 months	No