ST Segment Elevated Myocardial Infarction
Conditions
Keywords
STEMI, BMS, DES, mesh
Brief summary
The objective is to demonstrate that the Flow Area within a blocked coronary vessel as assessed by OCT is greater with the MGuard Prime stent compared to non-mesh control stent (BMS/DES) in subjects undergoing primary PCI for ST-segment elevation MI. The study hypothesis is that end of procedure flow area is greater with the MGuard Prime compared with stenting with a non-mesh DES or BMS.
Interventions
DEVICEMGuard Prime
DEVICEControl BMS DES
Sponsors
InspireMD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is \>18 years of age. * Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) of \>30 minutes and ≤12 hours in duration. * ST-segment elevation ≥1 mm per lead in ≥2 contiguous leads is present in at least one ECG prior to consent. * Subject agrees to all required follow-up procedures and visits. * Subject provides written, informed consent. * The target lesion is a single de novo lesion in a native coronary artery. * Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting. * TIMI flow of 0/1 is present at baseline and TIMI flow of 2/3 is present prior to randomization. * The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment, assessed after TIMI 2/3 flow is restored. * The entire lesion length requiring treatment is ≤33 mm by visual assessment, assessed after TIMI 2/3 flow is restored.
Exclusion criteria
* Currently enrolled in another investigational device or drug trial that has not reached the primary endpoint or that clinically interferes with the current study endpoints. * A previous coronary interventional procedure of any kind within 30 days - - - Female patients of childbearing potential. * Subject undergoing cardiopulmonary resuscitation (patients in whom cardiopulmonary resuscitation was successfully performed and in whom normal mental status was achieved, may be enrolled). * 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). * Prior administration of thrombolytic therapy for the current admission * Concurrent medical condition with a life expectancy of less than 12 months. * History of cerebrovascular accident or transient ischemic attack within the last 6 months, or any permanent neurologic deficit * Prior intracranial bleed at any time, or known intracranial pathology (e.g. tumor, arteriovenous malformation, or aneurysm). * Active or recent major bleeding within 6 months. * History of bleeding diathesis or coagulopathy or inability to accept blood transfusions. * Known hypersensitivity or contraindication to i) aspirin; or ii) heparin and bivalirudin; or iii) clopidogrel, prasugrel and ticagrelor; or iv) cobalt or nickel; or v) contrast media, which cannot be adequately pre-medicated (prior anaphylaxis, however, is an absolute contraindication to enrollment). * Known calculated creatinine clearance \<30 mL/min, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the minFA as measured by OCT at end of primary PCI (after stent deployment but before postdilatation), powered to demonstrate superiority of the MGuard Prime stent compared to the control arm. | immediate |
Countries
United Kingdom
Outcome results
None listed