acute coronary syndrome heart attack
Conditions
Interventions
At the index procedure, the culprit lesion (cause of complaints/acute coronary
syndrome) will be treated according to standard of care with a Biotronik Orsiro
DES (Sirolimus-Eluting stent). If there
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years or minimum age as required by local regulations 2. The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer*s Instructions for Use and the Declaration of Helsinki 3. Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the *Instructions for Use* that comes with every Biotronik Orsiro (Sirolimus-Eluting stent) system. Patients should qualify for both systems before randomization 4. The patient is willing and able to cooperate with study procedures and required follow up visits 5. The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization 6. diagnosed Acute coronary syndrome according to ESC guidelines/criteria 7. Multivessel disease
Exclusion criteria
Exclusion criteria: • Age 85 years • Single coronary vessel disease • Patients in cardiogenic shock • Patients who cannot give informed consent or have a life expectancy of less than 1year • Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors. • Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint The patient may only be enrolled once in the BioVAsc study • PCI in the previous 30 days. • Presence of a chronic total occlusion • Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding. • Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is defined as the composite of all-cause mortality, nonfatal type 1 myocardial infarction, any unplanned revascularization, and cerebrovascular events (MACCE) at 1-year post intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Composite clinical outcome of all-cause mortality, nonfatal type 1 myocardial infarction, any unplanned revascularization, and cerebrovascular events (MACCE) at 30 days, 2 and 5 years post intervention. • All-cause mortality at 30 days, 1, 2 and 5 years • Myocardial Infarction (Q-wave and non Q-wave MI) at 30 days, 1, 2 and 5 years • Any revascularization procedure, target lesion revascularization (TLR), Target Vessel Revascularization (TVR) and non-TVR at 30 days, 1, 2 and 5 years • Major bleeding (not related to coronary-artery bypass grafting, BARC 3-5) at 30 days and 1 year • Safety and efficacy of immediate complete revascularization in patient subgroups with specific demographics, clinical indications and/or vessel- or lesion characteristic • Net adverse clinical events at 30 days and one year, a composite of: • Major bleeding (not related to coronary-artery bypass grafting, BARC 3-5) • All-cause mortality, myocardial infarction or stroke • Need for renal replacement therapy at 30 days • Quality of Life at 30 days and 1 year Health status will be compared between the 2 groups using the Seattle Angina Questionnaire (SAQ) and the EQ 5D (EuroQol) assessment at 1 and 12 months post procedure. | — |
Countries
Netherlands
Outcome results
None listed