NCT03087175

MGuard Stent and Microcirculation

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

GUARDIANCORY study is a multicentre, prospective, randomized, non inferiority, open-label trial with a planned inclusion of 52 patients with STE and NSTE ACS and prescribed PCI. Patients will be randomized to benefiting either DES /BMS implantation (n=26) or MGuard stent (n=26) on the culprit lesion. Assessment of coronary microcirculation will be done by IMR immediately after PCI by using a pressure-temperature sensor-tipped coronary wire, thermodilution-derived.

Conditions

• Coronary Disease
• Coronary Artery Disease
• Coronary Atherosclerosis
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	MGuard stent	MGuard micronet mesh-covered stent in treatment of STE and NSTE-ACS
DEVICE	Drug eluting stent and bare metal stent	Drug eluting stent and bare metal stent in treatment of STE and NSTE-ACS For example, Resolute Onyx

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-11-07
• Completion: 2019-11-13
• First posted: 2017-03-22
• Last updated: 2022-05-25

Locations

2 sites across 1 country: France