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CompletedNCT01368471MASTERUpdated May 29, 2013

Safety and Efficacy Study of MGuard Stent After a Heart Attack

A Phase 4 interventional study of MGuard and Control BMS or DES in Myocardial Infarction, sponsored by InspireMD. Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-29.

Sponsored by InspireMD · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
433
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The goal of this study is to demonstrate the superiority of the MGuard™ stent over commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI).

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Conditions studied

  • Myocardial Infarction

Keywords

  • STEMI
  • myocardial infarction
  • stent
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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 433 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

InspireMD is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria

  • 18 years of age
  • ST-segment elevation (more than 2mm in more than contiguous leads)
  • MI with symptom onset less than 12h
  • The patient is willing to comply with specified follow-up evaluations
  • Signed ICF
  • Single de novo lesion in the target (culprit) vessel
  • Target lesion maximum length is 33 mm (by visual estimation)
  • Reference vessel diameter must be more than 3.0 to less than 4.0 mm by visual estimation
  • Randomization should occur as soon as Presence of TIMI 2 or 3 before randomization Exclusion Criteria
  • Pregnant or nursing patients
  • Left Bundle Branch Block (LBBB), paced rhythm, or other Electrocardiogram (ECG) abnormality
  • Impaired renal function
  • Prior coronary artery bypass graft surgery
  • Bleeding diathesis
  • Contraindication to aspirin
  • cardiopulmonary resuscitation
  • Cardiogenic shock
  • chronic warfarin anticoagulation
  • LVEF less than 20%
  • other medical illness
  • participation in another investigational drug or device study that has not reached its primary endpoint
  • Left main coronary artery disease with 50% stenosis
  • Ostial target lesion
  • Failure to visualize vessel anatomy distal to the culprit lesion
  • Moderate to heavily calcified target lesion or vessel
  • excessive tortuosity
  • bifurcation with a side branch more than 2.0 mm in diameter
  • A significant (greater than 50%) stenosis proximal or distal to the target lesion is present that cannot be covered by same single stent
  • Diffuse disease distal to target lesion with impaired runoff
  • Any prior stent proximal to the target lesion, or within 10 mm distal of the target lesion
  • PCI of another lesion performed within 6 months before the index procedure
  • Target lesion located in a saphenous vein graft
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
433 participants (actual)

Study arms

  • Experimental
    MGuard

    MGuard stent will be deployed

    Device: MGuard

  • Active comparator
    BMS or DES

    A regular bare metal stent or drug-eluting stent will be deployed

    Device: Control BMS or DES

Interventions

  • DeviceMGuard

    MGuard™ stent comprises a balloon-expandable, thin-strut stainless steel (316L) bare metal stent platform (strut width 100 µm) with mesh sleeve fibers of polyethyleneterephtalate (fiber width of 20 µm) attached to its outer surface. These fibers act like a net (aperture size 150 x 180 µm) preventing distal embolization of the plaque debris/thrombus placed between the vessel wall and the stent.

  • DeviceControl BMS or DES

    Control BMS or DES

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What researchers measure

Primary outcomes

  1. The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution

    Time frame: 60 to 90 minutes after the last angiogram

Secondary outcomes

  1. The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure.

    The incidence of TIMI 3 flow at the end of the procedure.

    Time frame: 60-90 minutes after last angiogram

  2. Major Adverse Cardiac Events (MACE)at discharge, 30 days, 6 months and 12 months post-procedure

    Major Adverse Cardiac Events (MACE): defined as cardiac death, reinfarction (Q wave and non-Q wave), or repeat ischemia-driven target lesion revascularization (TLR) by percutaneous or surgical methods at hospital discharge, 30 days, 6 months and 1 year post-procedure.

    Time frame: discharge, 30 days, 6 and 12 months post-procedure

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Study locations

7 sites
  • Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku
    Białystok, Poland
  • Gilghsin: John Paul II Hospital
    Krakow, Poland
  • Szpital Uniwersytecki w Krakowie
    Krakow, Poland
  • Oddział Kardiologii Inwazyjnej
    Nowy Targ, Poland
  • Centrum Kardiologii Inwazyjnej GVM Carint
    Oświęcim, Poland
  • Centralny Szpital Kliniczny MSWiA w Warszawie
    Warsaw, Poland
  • Milpark Hospital
    Johannesburg, South Africa
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References and documents

Publications

  • Dudek D, Dziewierz A, Brener SJ, Abizaid A, Merkely B, Costa RA, Bar E, Rakowski T, Kornowski R, Dressler O, Abizaid A, Silber S, Stone GW. Mesh-covered embolic protection stent implantation in ST-segment-elevation myocardial infarction: final 1-year clinical and angiographic results from the MGUARD for acute ST elevation reperfusion trial. Circ Cardiovasc Interv. 2015 Feb;8(2):e001484. doi: 10.1161/CIRCINTERVENTIONS.114.001484. PubMed 25603802 ↗
  • Dudek D, Brener SJ, Rakowski T, Dziewierz A, Abizaid A, Silber S, Yaacoby E, Dizon JM, Costa RA, Maehara A, Dressler O, Stone GW. Efficacy of an Embolic Protection Stent as a Function of Delay to Reperfusion in ST-Segment Elevation Myocardial Infarction (from the MASTER Trial). Am J Cardiol. 2014 Nov 15;114(10):1485-9. doi: 10.1016/j.amjcard.2014.08.007. Epub 2014 Aug 27. PubMed 25277335 ↗
  • Stone GW, Abizaid A, Silber S, Dizon JM, Merkely B, Costa RA, Kornowski R, Abizaid A, Wojdyla R, Maehara A, Dressler O, Brener SJ, Bar E, Dudek D. Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) in ST-Segment Elevation Myocardial Infarction: The MASTER Trial. J Am Coll Cardiol. 2012 Nov 6;60(19):1975-84. doi: 10.1016/j.jacc.2012.09.004. PubMed 23103033 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01368471
Lead sponsor
InspireMD
Responsible party
Sponsor
First posted
Jun 8, 2011
Start date
Jun 2011
Primary completion
Jun 2012
Completion
Jun 2012
Last update
May 29, 2013

Study contacts

Alexandre Abizaid, MD, PhD
principal investigator · Inst Dante Pazzanese of Cardiology, Brazil
Dariusz Dudek, MD, PhD
principal investigator · Cardiac Catheterization Laboratories, Krakow, Poland
Sigmund Silber, MD, PhD
principal investigator · Heart Center at the Isar Academic Teaching Site of the University of Munich
Gregg Stone, MD
study chair · Columbia University Medical Center The Cardiovascular Research Foundation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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