MGuard Stent and Microcirculation

NCT ID: NCT03087175

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-11-13

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MGuard stent

Intervention Type: DEVICE

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

Drug eluting stent and bare metal stent

Drug eluting stent and bare metal stent

Group Type: ACTIVE_COMPARATOR

Drug eluting stent and bare metal stent

Intervention Type: DEVICE

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

Interventions

MGuard stent

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

MGuard micronet mesh-covered stent; Resolute Onyx

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles BARONE-ROCHETTE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes

Locations

Annecy Hospital

Annecy, , France

University Hospital Grenoble

Grenoble, , France

Countries

France

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Other Identifiers

38RC15.311

Identifier Type: -

Identifier Source: org_study_id