Safety and Efficacy Study of MGuard Stent After a Heart Attack

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Device: MGuard; Device: Control BMS or DES

• Registration Number: NCT01368471
• Lead Sponsor: InspireMD

Brief Summary

The goal of this study is to demonstrate the superiority of the MGuard™ stent over commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-17
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 433

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MGuard	MGuard	MGuard stent will be deployed
BMS or DES	Control BMS or DES	A regular bare metal stent or drug-eluting stent will be deployed

Primary Outcome Measures

Name	Time	Method
The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution	60 to 90 minutes after the last angiogram

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)at discharge, 30 days, 6 months and 12 months post-procedure	discharge, 30 days, 6 and 12 months post-procedure	Major Adverse Cardiac Events (MACE): defined as cardiac death, reinfarction (Q wave and non-Q wave), or repeat ischemia-driven target lesion revascularization (TLR) by percutaneous or surgical methods at hospital discharge, 30 days, 6 months and 1 year post-procedure.
The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure.	60-90 minutes after last angiogram	The incidence of TIMI 3 flow at the end of the procedure.

Trial Locations

Locations (7)

Szpital Uniwersytecki w Krakowie; 🇵🇱 Krakow, Poland

Milpark Hospital; 🇿🇦 Johannesburg, South Africa

Centrum Kardiologii Inwazyjnej GVM Carint; 🇵🇱 Oświęcim, Poland

Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku; 🇵🇱 Białystok, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie; 🇵🇱 Warsaw, Poland

Oddział Kardiologii Inwazyjnej; 🇵🇱 Nowy Targ, Poland

Gilghsin: John Paul II Hospital; 🇵🇱 Krakow, Poland