Acute coronary syndromes Circulatory System Acute ischaemic heart disease, unspecified
Conditions
Interventions
Participants are randomised using the envelope method into two arms. Both groups undergo percutaneous coronary intervention (PCI): one arm undergoes bioresorbable stent implantation (Magmaris stent) a
Sponsors
Fakultní nemocnice Královské Vinohrady
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients were included if they presented with: 1. ST-elevation myocardial infarction (STEMI) <24 hours since the onset of symptoms or 2. Non-ST-elevation myocardial infarction (non-STEMI) or 3. Unstable angina caused by thrombotic acute coronary stenosis and coronary artery with stenosis diameter suitable for implantation of both investigated types of stents (vessel diameter between 2.7 and 3.7 mm)
Exclusion criteria
Exclusion criteria: 1. Cardiogenic shock or pulmonary oedema 2. Expected survival less than 3 years due to severe comorbidities 3. Contraindication of 12 months dual antiplatelet treatment including an indication to treatment with peroral anticoagulants 4. Diffuse calcifications or extreme tortuosity of the target vessel 5. In-stent restenosis or stent thrombosis as the culprit lesion 6. Left main stenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss assessed by quantitative coronary angiography (QCA) and optical coherance tomography (OCT) at 12 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Device and procedural success (devices implanted by physician with optimal expansion, time) recorded at the time of the procedure 2. Clinical combined endpoints (death, stent thrombosis, target vessel myocardial infarction, clinically driven target lesion failure), measured at 12 months 3. Magmaris resorption assessed by OCT at 12 months 4. Healing state assessed by OCT at 12 months | — |
Countries
Czech Republic
Contacts
Public ContactPetr Tousek
Outcome results
None listed