CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
MGuard stent +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03087175
NCT03087175N/ACompleted

Impact of Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) on Coronary Microcirculation's Lesions in Patients With ST or Non ST-segment Elevation Myocardial Infarction (STE and NSTE-ACS): Assessment by Index of Microcirculatory Resistance (IMR)

University Hospital, Grenoble·interventional·Posted Mar 22, 2017·Updated May 25, 2022

In Brief

A clinical study evaluating MGuard stent and Drug eluting stent and bare metal stent for Coronary Disease and 3 related conditions. Completed, enrolled 52 participants across 2 sites.

Detailed Summary

NSTE-ACS represents the most frequent indication for coronary angiography and percutaneous coronary intervention (PCI) worldwide. PCI permit to reestablished coronary flow but effectiveness of PCI within thrombus containing lesions is limited by the risk of occurrence of distal embolization and no-reflow phenomenon. Distal embolization lead to coronary microcirculation lesions. This complication is related to poor prognosis. MGuard stent is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh sleeve, which allows to prevent distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction. Index of microcirculatory resistance (IMR) is a validated method to assess coronary microcirculation. Accordingly, the purpose of this study is to demonstrate that MGuard micronet mesh-covered stent prevent distal embolization and microvascular reperfusion impairment during primary PCI, compared with a bare metal stent (BMS) and drug eluting stent (DES) in patients with NSTE-ACS, assessed by Index of microcirculatory resistance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 22, 2017
Enrollment StartDec 1, 2016
Primary CompletionNov 7, 2019
Study CompletionNov 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.3 years ago

Interventions

MGuard stentdevice

MGuard micronet mesh-covered stent in treatment of STE and NSTE-ACS

Drug eluting stent and bare metal stentdevice

Drug eluting stent and bare metal stent in treatment of STE and NSTE-ACS For example, Resolute Onyx