Myocardial infarction
Conditions
Interventions
Patients meeting all selection criteria are randomized to receive or STENTYS
stent or control stent (Abbott ML VISION stent or Medtronic Driver stent) in a
1 / 1 ratio.
Sponsors
Stentys
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects presenting with acute myocardial infarction with a de novo stenotic lesion in a native coronary artery amenable to revascularization with percutaneous coronary intervention with stent deployment.;Inclusion criteria 1.Subject >=18 years old. 2. Myocardial infarction 3. candidate for CABG 4. Patient understands nature of research and is willing to comply to follow-up investigations 5. vessel diameter is between 2.5 and 4.0 mm and length is
Exclusion criteria
Exclusion criteria: 1. Currently enrolled in another investigational study 2. Coronary or cardiac intervention or major surgery of any kind within 30 days prior to the procedure. 3. Patients on anticoagulation therapy (Coumadin) 4. Cardiogenic shock 5. Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study. 6. Cerebrovascular accident or transient ischemic attack in the last 6 months. 7. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, or sensitivity to contrast media, which cannot be adequately pre-medicated. 8. Known serum creatinine level >2.5mg/dl or presence or history of renal failure 9. Target lesion is severely calcified.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent strut malapposition at 3 days (±2 days) measured by OCT. Malapposition is defined as the distance between the leading edge of the strut and the leading edge of the contour bigger than the strut thickness. Side branches (with floating struts) will not be considered for analysis of the primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Major Adverse Cardiac Events (MACE): defined as cardiac death, re-MI, emergent bypass surgery (CABG), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 30 days, and 6 months post-procedure 2. Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q or Non Q-Wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods at 30 days and 6 months. 3. Acute Success Rates: a) Device Success: Attainment of 2.0 mm (TIMI | — |
Countries
Netherlands
Outcome results
None listed