About this trial
To evaluate the efficacy of the two DES (Drug Eluting Stent) used in terms of device-related adverse events at 12 months after PCI (Percutaneous Coronary Intervention).
To compare the clinical safety and efficacy by comparing net clinical events (defined as the combination of ischemic and hemorrhagic events) of the two DES used at 12 months after PCI.
Eligibility criteria
Qualifiers
Patients aged ≥18 years, and
Patients diagnosed with an acute coronary syndrome (ACS), either SCASEST (Acute Coronary Syndrome without Persistent ST-Segment Elevation) or IAMCEST (Acute Myocardial Infarction with Persistent ST-Segment Elevation), for which they will undergo PCI, and
Patients with de novo lesions in vessels with a reference diameter of ≥2.25 mm and ≤4.5 mm in whom implantation of one or more DES is clinically indicated, and
Patients who have been informed of the characteristics of the study and have provided written informed consent.
Disqualifiers
Patients in cardiogenic shock according to the severity criteria defined by the Society of Cardiovascular Angiography and Interventions (SCAI): "C" (Classic Shock), "D" (Deteriorating) and "E" (Extremis).
Patients unable to provide informed consent.
Patients with a known hypersensitivity or allergy to aspirin or any P2Y12 receptor inhibitor (clopidogrel, prasugrel, ticagrelor), heparin, contrast agents, or any of the components of DES.
Patients with active bleeding at the time of PCI requiring medical attention.
Trial design
Treatments tested in this trial
- ihtDEStiny® DES implanted
- Xience™ DES implanted