Please select the eligibility criteria that correspond to the clinical trial below.
Title: MASTER: MGUARD for Acute ST Elevation Reperfusion
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).


Options:
A: General Inclusion Criteria:

* Subject must be at least 18 years of age
* Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving XIENCE V® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
* Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
* Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
* Subject must agree to undergo all protocol-required follow-up procedures
* Subject must agree not to participate in any other clinical study for a period of one year following the index procedure

Angiographic Inclusion Criteria:

* Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and treatment of up to a three de novo target lesions, maximum of two de novo target lesions per epicardical vessel. (NOTE: RVD ≥2.5 mm to ≤3.75 mm until 4.0 mm TAXUS® is commercially available)
* Target lesion(s) must measure ≤28 mm in length by visual estimation(≥3 mm of non-diseased tissue on either side of the target lesion should be covered by the study stent)
* If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
* If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
* The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1
* Non-study, percutaneous intervention for lesions in a target vessel (including side branches) is allowed if done ≥ 9 months prior to the index procedure
* Non-study percutaneous intervention for lesions in a non-target vessel involving:
* Successful and uncomplicated (visually estimated diameter stenosis \< 50%, TIMI Grade 3 flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 24 hours prior to the index procedure or during (before randomization) the index procedure. For interventions done within 24 to 48 hours prior to the index procedure, CK and CK-MB must be assessed to be \< 2 times the upper limit of normal at the time of the index procedure. NOTE: Procedures within the 24 hour period preceding the index procedure are not permitted
* Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 30 days prior to the index procedure
* Drug-eluting stent treatment is allowed if done ≥ 90 days prior to the index procedure
* Non-study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if done ≥ 9 months after the index procedure

General Exclusion Criteria:

* Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure
* The subject is currently experiencing clinical symptoms consistent with AMI
* Subject has current unstable arrhythmias
* Subject has a known left ventricular ejection fraction (LVEF) \< 30%
* Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
* Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
* Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.)
* Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
* Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated
* Elective surgery that will require discontinuing either aspirin or clopidogrel is planned within the first 9 months after the procedure
* Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
* Subject has known renal insufficiency (e.g., serum creatinine level of \> 2.5 mg/dL or subject on dialysis)
* Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
* Subject has had a significant GI or urinary bleed within the past six months
* Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
* Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year
* Subject is already participating in another clinical study that has not yet reached its primary endpoint
* Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used up to 1 year following the index procedure)
* Angiographic Exclusion Criteria
* The target lesion(s) meets any of the following criteria:
* Left main coronary artery location including left main ostial location (NOTE: RCA-aorto-ostial lesions are not excluded)
* Located within 2 mm of the origin of the LAD or LCX
* Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and any visually estimated diameter stenosis \> 20%) arterial or saphenous vein graft
* Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is \> 50% stenosed by visual estimation
* Involves a side branch requiring pre-dilatation
* Total occlusion (TIMI flow 0) prior to wire crossing
* Excessive tortuosity proximal to or within the lesion
* Extreme angulation (≥ 90º) proximal to or within the lesion
* Heavy calcification
* Restenotic from previous intervention
* Subject has received brachytherapy in any epicardial vessel (including side branches)
* The target vessel contains thrombus
* Another clinically significant lesion in the target vessel is present that requires or has a high probability of requiring PCI during the index procedure
* Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 9 months after the index procedure
B: Inclusion Criteria:

Inclusion criteria were an age of more than 18 years, the presence for at least 30 minutes but less than 12 hours of symptoms consistent with acute myocardial infarction, and the presence of ST-segment elevation in at least two contiguous leads or left bundle-branch block.

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Exclusion Criteria:

Patients were excluded if they were in cardiogenic shock (defined as systolic blood pressure of less than 80 mm Hg for more than 30 minutes or the need for intravenous pressors or intraaortic-balloon counterpulsation); had a history of bleeding diathesis; had a history of leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction; had a noncardiac illness associated with a life expectancy of less than one year; were participating in another study; or were unable to give informed consent owing to prolonged cardiopulmonary resuscitation.

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C: 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
D: Inclusion Criteria:

* Subject is \> 18 years and \< 80 years of age
* Written subject informed consent available prior to PCI
* Subjects with stable or unstable angina pectoris or documented silent ischemia
* Subject eligible for PCI
* Subject acceptable candidate for coronary artery bypass surgery
* Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
* Reference vessel diameter between 2.2-3.8 mm by visual estimation
* Target lesion length ≤ 21 mm by visual estimation
* Target lesion stenosis by visual estimation, assisted by QCA / IVUS: \> 50% - \< 100%
* Eligible for Dual Anti Platelet Therapy (DAPT)

Exclusion Criteria:

* Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
* Evidence of myocardial infarction within 72 hours prior to index procedure
* Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
* Unprotected left main coronary artery disease
* Three-vessel coronary artery disease at time of procedure
* Thrombus in target vessel
* Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
* Planned interventional treatment of any non-target vessel within 30 days post-procedure
* Subjects on dialysis
* Planned intervention of the target vessel within 6-month after the index procedure
* Ostial target lesion (within 5.0 mm of vessel origin)
* Target lesion involves a side branch \>2.0 mm in diameter
* Documented left ventricular ejection fraction (LVEF) ≤ 30%
* Heavily calcified lesion
* Target lesion is located in or supplied by an arterial or venous bypass graft
* The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to, rotational atherectomy, cutting balloon etc.)
* Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
* Impaired renal function (serum creatinine \> 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
* Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
* Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
* Life expectancy less than 1 year
* Planned surgery or dental surgical procedure within 6 months after index procedure
* In the investigators opinion subjects will not be able to comply with the follow-up requirements

Answer: C