Safety and Efficacy Study of MGuard Stent After a Heart Attack (MASTER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01368471
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : May 29, 2013
Information provided by (Responsible Party):

Brief 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).

Condition or disease Intervention/treatment Phase
Myocardial Infarction Device: MGuard Device: Control BMS or DES Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: MASTER: MGUARD for Acute ST Elevation Reperfusion
Study Start Date : June 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: MGuard
MGuard stent will be deployed
Device: MGuard
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.

Active Comparator: BMS or DES
A regular bare metal stent or drug-eluting stent will be deployed
Device: Control BMS or DES
Control BMS or DES

Primary Outcome Measures :
  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 Outcome Measures :
  1. The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure. [ Time Frame: 60-90 minutes after last angiogram ]
    The incidence of TIMI 3 flow at the end of the procedure.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01368471

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
South Africa
Milpark Hospital
Johannesburg, South Africa
Sponsors and Collaborators
Principal Investigator: Alexandre Abizaid, MD, PhD Inst Dante Pazzanese of Cardiology, Brazil
Principal Investigator: Dariusz Dudek, MD, PhD Cardiac Catheterization Laboratories, Krakow, Poland
Principal Investigator: Sigmund Silber, MD, PhD Heart Center at the Isar Academic Teaching Site of the University of Munich
Study Chair: Gregg Stone, MD Columbia University Medical Center The Cardiovascular Research Foundation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: InspireMD Identifier: NCT01368471     History of Changes
Other Study ID Numbers: IMD-07
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by InspireMD:
myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases