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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InspireMD
ClinicalTrials.gov Identifier:
NCT01368471
First received: February 17, 2011
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Myocardial Infarction
 Device: MGuard
Device: Control BMS or DES
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: MASTER: MGUARD for Acute ST Elevation Reperfusion

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by InspireMD:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure. [ Time Frame: 60-90 minutes after last angiogram ] [ Designated as safety issue: No ]
    The incidence of TIMI 3 flow at the end of the procedure.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 432
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368471

Locations
Poland
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
InspireMD
Investigators
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
  More Information

No publications provided

Responsible Party: InspireMD
ClinicalTrials.gov Identifier: NCT01368471     History of Changes
Other Study ID Numbers: IMD-07
Study First Received: February 17, 2011
Last Updated: June 11, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by InspireMD:
STEMI
myocardial infarction
stent

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

ClinicalTrials.gov processed this record on May 22, 2013