MGuard Stent and Microcirculation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Coronary Disease, Coronary Artery Disease, Coronary Atherosclerosis, Cardiovascular Diseases

Intervention / Treatment
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* Device: MGuard stent
* Device: Drug eluting stent and bare metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Patients affiliated to social security Patients with an NSTEMI or STEMI (1) Thrombus containing coronary lesions on angiography (TIMI thrombus grade ≥ 3) Eligible patients for revascularization with angioplasty Patients consenting to participate in the study. Exclusion Criteria: Age < 18 years Prior myocardial infarction Prior CABG Inability to comply with the protocol Major patient protected by law (article L1121-8), Person deprived of liberty (article L1121-8), Pregnant woman Breastfeeding women Patient with terminal illness, Terminal Renal failure Allergy to iodine Adenosine's contraindications: Asthmatic patients, Second- or third-degree AV block without a pacemaker or sick sinus syndrome. Systolic blood pressure less than 90mmHg. Recent use of dipyridamole or dipyridamole-containing medications, Methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test. Known hypersensitivity to adenosine. Unstable acute myocardial infarction or acute coronary syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGuard stent<br>MGuard stent is a novel thin-strut metal stent with a polyethylene terephthalate micronet covering designed to trap and exclude thrombus and friable atheromatous debris to prevent distal embolization | Device: MGuard stent<br>* MGuard micronet mesh-covered stent in treatment of STE and NSTE-ACS<br>* Other names: MGuard micronet mesh-covered stent;|
| Active Comparator: Drug eluting stent and bare metal stent<br>Drug eluting stent and bare metal stent | Device: Drug eluting stent and bare metal stent<br>* Drug eluting stent and bare metal stent in treatment of STE and NSTE-ACS For example, Resolute Onyx<br>* Other names: Resolute Onyx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index of microcirculatory resistance (IMR) | Index of microcirculatory resistance (IMR) will be measured with a pressure sensor/thermistor-tipped guidewire | During the 2 hours after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIMI flux on angiography |  | During the 2 hours after randomization | 
| Grade blush on angiography |  | During the 2 hours after randomization | 
| TIMI frame count measure |  | During the 2 hours after randomization | 
| Measure of risk area by BARI-Score |  | During the 2 hours after randomisation | 
| ST-segment resolution defined by >70% ST-segment resolution on EKG post angioplasty compared to initial EKG |  | During the 24 hours after randomization | 
| Enzymatic cycle with measure of troponin T and CPK pick |  | 7 days after randomization | 
| Measure of wall motion score (WMS) by echocardiography |  | 2, 7 days after randomization, 6 month follow-up | 
| Measure of 2D strain by echocardiography |  | 2, 7 days after randomization, 6 month follow-up | 
| Cardiological follow up to detect intrastent restenosis |  | 6 month follow-up |