The effectiveness of new bioresorbable coronary stents in the treatment of patients with acute coronary syndromes
- Conditions
- Acute coronary syndromesCirculatory SystemAcute ischaemic heart disease, unspecified
- Registration Number
- ISRCTN89434356
- Lead Sponsor
- Fakultní nemocnice Královské Vinohrady
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34505954/ (added 13/09/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ate lumen loss assessed by quantitative coronary angiography (QCA) and optical coherance tomography (OCT) at 12 months follow-up
- Secondary Outcome Measures
Name Time Method <br> 1. Device and procedural success (devices implanted by physician with optimal expansion, time) recorded at the time of the procedure<br> 2. Clinical combined endpoints (death, stent thrombosis, target vessel myocardial infarction, clinically driven target lesion failure), measured at 12 months<br> 3. Magmaris resorption assessed by OCT at 12 months<br> 4. Healing state assessed by OCT at 12 months<br>