heart-attack myocardial infarction
Conditions
Interventions
Two treatment groups will be assessed:
- STENTYS DES (S) self-expandable stent (SE) stent
- DES balloon-expandable stent (BE) Zotarolimus-eluting (Medtronic Resolute)
The antiplatelet therapy in bo
Sponsors
Stentys
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: clinical: 1. Aged between 18 and 80 years. 2. Patients with ST-elevation myocardial infarction in the ambulance or in the cathlab >= 0.2 mV of ST-segment elevation in at least two consecutive leads, = 20 min 3. Target lesion is a de novo lesion 4. Signed authorization for informed patients Angiography: 5. Diameter of the vessel is between 2.5 and 4.0mm corresponding to the available STENTYS and Resolute stent sizes (by visual assessment). 6. Target lesion
Exclusion criteria
Exclusion criteria: clinical: 1. Pregnant women or nursing woman or woman of childbearing age without adequate contraception 2. Participation in another clinical study that the primary endpoint has not yet reached, or which interferes with the current study endpoints. 3. Coronary intervention or cardiac or major surgery 30% (visual assessment) 17. Patients with significant lesions in two coronary arteries that require additional treatment within 30 days. 18. Patients with significant lesions in all three coronary arteries 19. Target lesion is a chronic total occlusion 20. Perforated drum, demonstrated by leakage of contrast. 21. Aneurysmal dilation, proximal or distal to the lesion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of stent strut malapposistie at 9 months, assessed by OCT. | — |
Secondary
| Measure | Time frame |
|---|---|
| OCT endpoint at 4 months: 1. Percentage of stent strut malapposistie OCT endpoints at 4 or 9 months: 2. Percentage of bare stent struts 3. Healing Score 4. Mean Flow area / volume. (Average flow surface / volume) 5. Intraluminal defect area / volume. (Defective intraluminal surface / volume) 6. Mean stent area / volume. (Mean stent area / volume) 7. Incomplete Stent Apposition (ISA) area / volume (Incomplete stent apposition) 8. Tissue prolapse area / volume. (Surface tissue by the struts / volume) Clinical secondary endpoints: 9. Procedure success: = 50%) on 4 / 9 months. 20. TIMI flow pre-and post-procedure and at follow-up. 21. TIMI (corrected) frame count post procedure. 22. Myocardial blush grade post-procedure. ECG endpoint: 23. ST segment elevation resolution:% reduction of ST-segment elevation 90 ± 30 minutes after the procedure. IMR endpoint: 24. Index of microvascular resistance (IMR Index of micro-vascular resistance) post procedure (selected sites) 25. Percentage of patients with an IMR | — |
Countries
Netherlands
Outcome results
None listed