MGuard Stent and Microcirculation (GUARDIANCORY)

May 18, 2022 updated by: University Hospital, Grenoble

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France
        • Annecy Hospital
      • Grenoble, France
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Gilles BARONE-ROCHETTE, MD, PhD, CHU Grenoble Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

November 7, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC15.311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on MGuard stent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe