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MGuard Stent and Microcirculation (GUARDIANCORY)

Primary Purpose

Coronary Disease, Coronary Artery Disease, Coronary Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MGuard stent
Drug eluting stent and bare metal stent
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Annecy Hospital
  • University Hospital Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MGuard stent

Drug eluting stent and bare metal stent

Arm Description

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

Drug eluting stent and bare metal stent

Outcomes

Primary Outcome Measures

Index of microcirculatory resistance (IMR)
Index of microcirculatory resistance (IMR) will be measured with a pressure sensor/thermistor-tipped guidewire

Secondary Outcome Measures

TIMI flux on angiography
Grade blush on angiography
TIMI frame count measure
Measure of risk area by BARI-Score
ST-segment resolution defined by >70% ST-segment resolution on EKG post angioplasty compared to initial EKG
Enzymatic cycle with measure of troponin T and CPK pick
Measure of wall motion score (WMS) by echocardiography
Measure of 2D strain by echocardiography
Cardiological follow up to detect intrastent restenosis

Full Information

First Posted
November 14, 2016
Last Updated
May 18, 2022
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03087175
Brief Title
MGuard Stent and Microcirculation
Acronym
GUARDIANCORY
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 Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Coronary Artery Disease, Coronary Atherosclerosis, Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MGuard stent
Arm Type
Experimental
Arm Description
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
Arm Title
Drug eluting stent and bare metal stent
Arm Type
Active Comparator
Arm Description
Drug eluting stent and bare metal stent
Intervention Type
Device
Intervention Name(s)
MGuard stent
Other Intervention Name(s)
MGuard micronet mesh-covered stent
Intervention Description
MGuard micronet mesh-covered stent in treatment of STE and NSTE-ACS
Intervention Type
Device
Intervention Name(s)
Drug eluting stent and bare metal stent
Other Intervention Name(s)
Resolute Onyx
Intervention Description
Drug eluting stent and bare metal stent in treatment of STE and NSTE-ACS For example, Resolute Onyx
Primary Outcome Measure Information:
Title
Index of microcirculatory resistance (IMR)
Description
Index of microcirculatory resistance (IMR) will be measured with a pressure sensor/thermistor-tipped guidewire
Time Frame
During the 2 hours after randomization
Secondary Outcome Measure Information:
Title
TIMI flux on angiography
Time Frame
During the 2 hours after randomization
Title
Grade blush on angiography
Time Frame
During the 2 hours after randomization
Title
TIMI frame count measure
Time Frame
During the 2 hours after randomization
Title
Measure of risk area by BARI-Score
Time Frame
During the 2 hours after randomisation
Title
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
Title
Enzymatic cycle with measure of troponin T and CPK pick
Time Frame
7 days after randomization
Title
Measure of wall motion score (WMS) by echocardiography
Time Frame
2, 7 days after randomization, 6 month follow-up
Title
Measure of 2D strain by echocardiography
Time Frame
2, 7 days after randomization, 6 month follow-up
Title
Cardiological follow up to detect intrastent restenosis
Time Frame
6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles BARONE-ROCHETTE, MD, PhD
Organizational Affiliation
CHU Grenoble Alpes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Annecy Hospital
City
Annecy
Country
France
Facility Name
University Hospital Grenoble
City
Grenoble
Country
France

12. IPD Sharing Statement

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MGuard Stent and Microcirculation

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