MGuard stent
DeviceMGuard micronet mesh-covered stent in treatment of STE and NSTE-ACS
Other names: MGuard micronet mesh-covered stent
NCT Number: NCT03087175
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Annecy Hospital, Annecy, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MGuard micronet mesh-covered stent in treatment of STE and NSTE-ACS
Other names: MGuard micronet mesh-covered stent
Drug eluting stent and bare metal stent in treatment of STE and NSTE-ACS For example, Resolute Onyx
Other names: Resolute Onyx
Time frame: During the 2 hours after randomization
Index of microcirculatory resistance (IMR) will be measured with a pressure sensor/thermistor-tipped guidewire
Time frame: During the 2 hours after randomization
Time frame: During the 2 hours after randomization
Time frame: During the 2 hours after randomization
Time frame: During the 2 hours after randomisation
Time frame: During the 24 hours after randomization
Time frame: 7 days after randomization
Time frame: 2, 7 days after randomization, 6 month follow-up
Time frame: 2, 7 days after randomization, 6 month follow-up
Time frame: 6 month follow-up
University Hospital, Grenoble
Other
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)
Acronym: GUARDIANCORY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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