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Completed

NCT Number: NCT03087175

MGuard Stent and Microcirculation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Annecy Hospital, Annecy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MGuard stent

Device

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

Other names: MGuard micronet mesh-covered 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

Other names: Resolute Onyx

Primary outcomes

  1. 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

Secondary outcomes

  1. TIMI flux on angiography

    Time frame: During the 2 hours after randomization

  2. Grade blush on angiography

    Time frame: During the 2 hours after randomization

  3. TIMI frame count measure

    Time frame: During the 2 hours after randomization

  4. Measure of risk area by BARI-Score

    Time frame: During the 2 hours after randomisation

  5. 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

  6. Enzymatic cycle with measure of troponin T and CPK pick

    Time frame: 7 days after randomization

  7. Measure of wall motion score (WMS) by echocardiography

    Time frame: 2, 7 days after randomization, 6 month follow-up

  8. Measure of 2D strain by echocardiography

    Time frame: 2, 7 days after randomization, 6 month follow-up

  9. Cardiological follow up to detect intrastent restenosis

    Time frame: 6 month follow-up

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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)

Acronym: GUARDIANCORY

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2017
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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