*MGuard* Prime Stent System Clinical Trial in Patients with Acute ST Elevation Myocardial Infarction*.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 110

Inclusion Criteria

General Inclusion Criteria
1. Subject is * 18 years of age.
2. Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) of >30 minutes and *12 hours in duration.
3. ST elevation *2 mm per lead in *2 contiguous leads is present in one ECG prior to consent.
4. Subject agrees to all required follow-up procedures and visits.
5. Subject provides written, informed consent.;Angiographic Inclusion Criteria
1. The target lesion is a de novo lesion in a native coronary artery.
2. Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.
3. The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment, assessed either at baseline (if direct stenting is planned), or after pre-dilatation or thrombus aspiration (if direct stenting is not planned).
4. The entire lesion length requiring treatment is *24 mm (able to be covered by a single study stent), assessed either at baseline (if direct stenting is planned), or after pre-dilatation or thrombus aspiration (if direct stenting is not planned)
5. TIMI flow of 2/3 is present prior to randomization (in case of baseline TIMI flow 0/1, blood flow must be restored).

Exclusion Criteria

General Exclusion Criteria
1. Left bundle branch block (LBBB), paced rhythm, or other ECG abnormality interfering with assessment of ST-segment.
2. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
3. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
4. Female patients of childbearing potential.
5. Subject undergoing cardiopulmonary resuscitation (patients in whom cardiopulmonary resuscitation was successfully performed and in whom normal mental status was achieved, may be enrolled).
6. Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or intra-aortic balloon bump (IABP) or other hemodynamic support device for hypotension).
7. The subject requires a staged procedure of the target vessel (including branches) within 12 months or of any non-target vessel within 7 days post-procedure.
8. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to excimer laser, rotational atherectomy, etc.). Manual thrombus aspiration may be used per operator discretion, but rheolytic thrombectomy is only permitted for procedural complications after randomization.
9. Prior administration of thrombolytic therapy for the current admission
10. Co-morbid condition(s) that could limit the subject*s ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
11. Concurrent medical condition with a life expectancy of less than 12 months.
12. History of cerebrovascular accident or transient ischemic attack within the last 6 months, or any permanent neurologic deficit
13. Prior intracranial bleed at any time, or known intracranial pathology (e.g. tumor, arteriovenous malformation, or aneurysm).
14. Active or recent site of major bleeding within 6 months.
15. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
16. Known hypersensitivity or contraindication to either i) aspirin, or heparin and bivalirudin; or ii) clopidogrel , ticlopidine, prasugrel and ticagrelor; or iii) cobalt or nickel; or iv) contrast media, which cannot be adequately pre-medicated (prior anaphylaxis, however, is an absolute contraindication to enrollment).
17. Known serum creatinine level >2.5 mg/dl, hemoglobin <10 g/dL or platelet count <150,000 for the present admission or within 7 days prior to index procedure, if available. NOTE: Baseline labs do not have to be available to consent patient. If laboratory results become available only after randomization, and do not meet inclusion and exclusion criteria, the patient will not be de-registered from the study.
18. Surgery planned or any other reason necessitating discontinuation of dual anti-platelet therapy (aspirin and an ADP antagonist) within 12 months
19. Aortic dissection or mechanical complication of STEMI (papillary muscle rupture, ventricular septal defect or free wall rupture with or without pseudoaneurysm) identified by echocardiography or other means;Angiographic Exclusion Criteria
1. Unprotected left main stenosis *50%.
2. Multi-vessel intervention required during the index procedure.
3. Excessive tortuosity, calcification or diffuse distal disease is present either proximal to, at or dista

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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