ST-segment elevation myocardial infarction Myocardial infarction, STEMI
Conditions
Interventions
1. Perfusion balloon (PB) group
Perfusion balloon dilatation for 3 minutes and intermittent intracoronary administration of nicorandil prior to BioFreedom Ultra stent implantation
2. Direct stent (DS)
Balloon dilations
Pre-dilatation
Sponsors
Muramatsu Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with type 1 ST-segment elevation myocardial infarction (STEMI) within 24 hours of last symptom onset who are eligible for primary PCI and for whom one or more BioFreedom Ultra stents can be implanted in the native (de novo) culprit coronary lesion. 2. Subjects who understand the context of the trial and have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients under 18 years old 2. Patients who are unable to give informed consent 3. Patients who are pregnant or may become pregnant 4. Patients who are already participating in other clinical studies 5. Patients with severe cerebral, hepatic, or renal dysfunction (including dialysis cases) 6. Patients with Eisenmenger's syndrome or primary pulmonary hypertension 7. Patients receiving phosphodiesterase 5 (PDE5) inhibitors or guanylate cyclase (sGC) stimulating agents 8. Patients with angle-closure glaucoma 9. Patients classified as Type 2-5 acute myocardial infarction 10. Patients with hypotention or cardiogenic shock, or those who have undergone extracorporeal circulatory support (MCS) such as IABP/Impella/VA-ECMO(PCPS) prior to primary PCI 11. Patients with a reference vessel diameter of less than 2.5 mm or greater than 4.0 mm in the culprit lesion 12. Unprotected left main coronary artery lesion 13. Patients who require atherectomy before stenting (e.g. heavily calcified lesions) 14. Patients with known metallic allergy or hypersensitivity of Rapamycin analogues, nicorandil or nitrates 15. Patients for whom stenting is considered undesirable in primary PCI 16. Patients who are deemed inappropriate by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of slow flow or no-reflow during primary PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| - Corrected TIMI frame count - ST-segment resolution - Sigma ST-segment elevation - Door-to-Balloon time - PCI procedure time - Radiocontrast volume - Fluoroscopy time, radiation exposure - Ventricular tachyarrythmia during PCI - MCS use during or after primary PCI - Stent thrombosis - Major bleeding events defined as BARC 3 or 5 | — |
Contacts
Public ContactTakashi Muramatsu
Fujita Health University Hospital
Outcome results
None listed