Comparison of a Contemporary Sirolimus-eluting Stent (ihtDEStiny®) With Another Everolimus-eluting Stent (Xience™), Both With Permanent Polymers, in Patients With Acute Coronary Syndrome and de Novo Coronary Artery Lesions (DestinACSion)

Fundación EPIC

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Device: Xience™ DES implanted

Device: ihtDEStiny® DES implanted

Study type

Interventional

Funder types

Other

Identifiers

NCT07190690

EPIC45-DestinACSion

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2,100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who meet ALL inclusion criteria will be included:

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.

Exclusion criteria

Patients must not meet any of the following exclusion criteria:

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.
Patients with planned surgery within the next 3 months.
Patients with any medical condition that limits a life expectancy of less than 12 months.
Patients participating in another clinical trial in which the primary endpoint was not met.
Pregnant or breastfeeding women of childbearing potential with a positive pregnancy test.