MGuard Stent and Microcirculation

NCT03087175 | Completed

• 1 other identifier: 38RC15.311
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Atherosclerosis; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

MGuard stent

EXPERIMENTAL

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

Drug eluting stent and bare metal stent

ACTIVE COMPARATOR

Drug eluting stent and bare metal stent

Device: Drug eluting stent and bare metal stent

Interventions

MGuard stent DEVICE

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

Also known as: MGuard micronet mesh-covered stent

MGuard stent

Drug eluting stent and bare metal stent DEVICE

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

Also known as: Resolute Onyx

Drug eluting stent and bare metal stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

Annecy Hospital

Annecy, France

Location

University Hospital Grenoble

Grenoble, France

Location

Related Publications (23)

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MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Cardiovascular Diseases

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Gilles BARONE-ROCHETTE, MD, PhD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: March 22, 2017
• Study Start: December 1, 2016
• Primary Completion: November 7, 2019
• Study Completion: November 13, 2019
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

FR (2)