Clinical trial NCT01368471: Safety and Efficacy Study of MGuard Stent After a Heart Attack
Official title: MASTER: MGUARD for Acute ST Elevation Reperfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: STEMI
myocardial infarction
stent
Lead sponsor: InspireMD
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution
timeFrame: 60 to 90 minutes after the last angiogram
Secondary outcomes:
measure: The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure.
timeFrame: 60-90 minutes after last angiogram
measure: Major Adverse Cardiac Events (MACE)at discharge, 30 days, 6 months and 12 months post-procedure
timeFrame: discharge, 30 days, 6 and 12 months post-procedure
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku
city: Krakow
country: Poland
facility: Gilghsin: John Paul II Hospital
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Nowy Targ
country: Poland
facility: Oddział Kardiologii Inwazyjnej
city: Oświęcim
country: Poland
facility: Centrum Kardiologii Inwazyjnej GVM Carint
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
city: Johannesburg
country: South Africa
facility: Milpark Hospital
Study officials:
affiliation: Inst Dante Pazzanese of Cardiology, Brazil
name: Alexandre Abizaid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiac Catheterization Laboratories, Krakow, Poland
name: Dariusz Dudek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center at the Isar Academic Teaching Site of the University of Munich
name: Sigmund Silber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University Medical Center The Cardiovascular Research Foundation
name: Gregg Stone, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.