ST segment elevation myocardial infarction
Conditions
Interventions
Blood samples will be taken at the follow up visits, after 30 days, 6 months
and 12 months. A total amount of 50 ml of blood will be taken per visit. A
follow up angiographic will be done 6 months a
Sponsors
OrbusNeich Medical CO. LTD
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must meet ALL of the following criteria: 1. Patient >= 18 and = 1 mm in >= 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >= 1 mm in >= 2 contiguous anterior leads. 3. Treatment of one or two de novo lesions in the same vessel with a total lesion length of = 2.5 and 1 hour but subsequently resolved, may still be enrolled if the ECG, at the time of the evaluation, shows definitive ongoing ST segment elevation.
Exclusion criteria
Exclusion criteria: 1. Woman who are preganant or woman of childbearing potential who do not use adequate contraception. 2. Recipient of heart transplant. 3. Any patient who previously received murine therapeutic antibodies and is know to have exhibited sensitization through the production of Human Anti-mouse Antibodies (HAMA). 4. Patient with life expectancy less than the follow-up period (12 months). 5. Know allergies to aspirin, clopidogrel bisulphate an ticlopidin, heparin or stainless steel. 6. Patients pesenting with cardiogenic shock. 7. Received thrombolytic therapy for the current STEMI. 8. Lesion is not suitable for stenting. 9. Any significant medical condition which in the investigator's opinion may interfere with the patient's optinonal participation in the study. 10. Currently participatinf in an investigational drug or antother device study or subject to inclusion in another investigational srug or other another device study during follow-up. 11. Unprotected left main coronary disease with >50% stenosis. 12. Ostial target lesions. 13. Calcified lesions which cannot be successfully predilated. 14. Targer lesion has excessive tortuosity unsuitable for stent delivery and deplyment. 15. Target lesion involves bifurcation including a side brach >2.5 mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require stenting of diseased side branch). 16. A significant (>50%) stenosis proximal or distal to the target lesion or in another vessel that is not the infarct lesion and requires treatmetn during the acute procedure or within 30 days of enrollment. 17. Documented ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early stent thrombosis at 30 days post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| · Device, lesion, angiographic and procedure success · Clinically-driven Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6 and 12 months · Major Adverse Cardiac Events (MACE) at 30 days, 6 and 12 months · Stent thrombosis at 6 months and 12 months (include early and late, probable and definite). · Late stent thrombosis (definite and probable). · In-stent and in-lesion minimum lumen diameter (MLD), % diameter stenosis (DS), late loss and angiographic binary restenosis (> 50% DS) at 6 months post procedure. Data Coordinating Analysis Center | — |
Countries
Netherlands
Outcome results
None listed