GUARDIANCORY: MGuard Stent and Microcirculation

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT03087175

Collaborator

(none)

Enrollment

Locations

Arms

35.4

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease Coronary Artery Disease Coronary Atherosclerosis Cardiovascular Diseases	Device: MGuard stent Device: Drug eluting stent and bare metal stent	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Nov 7, 2019

Actual Study Completion Date :

Nov 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MGuard stent 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 MGuard micronet mesh-covered stent in treatment of STE and NSTE-ACS Other Names: MGuard micronet mesh-covered stent
Active Comparator: Drug eluting stent and bare metal stent Drug eluting stent and bare metal stent	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 Other Names: Resolute Onyx

Arm

Intervention/Treatment

Experimental: MGuard stent

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

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

Other Names:

MGuard micronet mesh-covered stent

Active Comparator: Drug eluting stent and bare metal stent

Drug eluting stent and bare metal stent

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

Other Names:

Resolute Onyx

Outcome Measures

Primary Outcome Measures

Index of microcirculatory resistance (IMR) [During the 2 hours after randomization]
Index of microcirculatory resistance (IMR) will be measured with a pressure sensor/thermistor-tipped guidewire

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.