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

InspireMD

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Device: MGuard; Device: Control BMS or DES

Study type: Interventional

Funder types: Industry

Identifiers

NCT01368471

IMD-07

Details and patient eligibility

About

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).

Enrollment: 433 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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433 participants in 2 patient groups

MGuard

Experimental group

Description:

MGuard stent will be deployed

Treatment:

Device: MGuard

BMS or DES

Active Comparator group

Description:

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

Treatment:

Device: Control BMS or DES