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

N/ARecruitingNCT07190690

Fundación EPIC2,100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,100

Conditions

Coronary Artery Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (13)

Hospital Universitario San Juan Alicante

Alicante, Spain

RECRUITING

Hospital Universitari Germans Trias I Pujol

Badalona, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

Hospital Universitario Virgen de La Arrixaca

El Palmar, Spain

RECRUITING

Hospital Universitario La Paz

Fuencarral-El Pardo, Spain

RECRUITING

Hospital Universitario Juan Ramón Jiménez

Huelva, Spain

RECRUITING

Hospital Universitario de Leon

León, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, Spain

RECRUITING

Hospital Universitario Lucus Agustí

Lugo, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, Spain

RECRUITING

...and 3 more locations

Outcomes

Primary Outcomes

EFFICACY: Device-oriented Composite Endpoint (DoCE)

Composite clinical endpoint cardiac Rate at 12 months cause death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)

Time frame: 12 months

NACE

Composite clinical endpoint Rate of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events

Time frame: 12 months

Secondary Outcomes

All-Cause Death Rate at 12 months

Time frame: 12 months

All-Cause Death Rate at 24 months

Time frame: 12 months

Cardiac Death Rate at 12 months

Time frame: 12 months

Cardiac Death Rate at 24 months

Time frame: 12 months

Myocardial Infarction Rate at 12 months

Time frame: 12 months

Myocardial Infarction Rate at 24 months

Time frame: 12 months

Periprocedural myocardial infarction Rate

Time frame: PCI procedure

Definite/Probable stent thrombosis rate at 12 months

Time frame: 12 months

Definite/Probable stent thrombosis rate at 24 months

Time frame: 24 months

Any stroke at 12 months

Stroke Rate at 12 months

Time frame: 12 months

Any stroke at 24 months

Stroke Rate at 24 months

Time frame: 12 months

BARC type 2 ,3 or 5 bleeding events at 12 months

Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria at 12 months

Time frame: 12 months

BARC type 2 ,3 or 5 bleeding events at 24 months

Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria at 24 months

Time frame: 24 months

Target vessel revascularization Rate at 12 months

Time frame: 12 months

Target vessel revascularization Rate at 24 months

Time frame: 24 months

Target vessel Failure (TVF) Rate at 12 months

Time frame: 12 months

Target vessel Failure (TVF) Rate at 24 months

Time frame: 24 months

Target Lesion Failure (TLF) Rate at 12 months

Time frame: 12 months

Target Lesion Failure (TLF) Rate at 24 months

Time frame: 24 months

Target Vessel Revascularization Rate (TVR) at 12 months

Time frame: 12 months

Target Vessel Revascularization Rate (TVR) at 24 months

Time frame: 24 months

Target lesion ischemia-guided revascularization Rate at 12 months

Time frame: 12 months

Target lesion ischemia-guided revascularization Rate at 24 months

Time frame: 24 months

Repeated revascularization Rate at 12 months

Time frame: 12 months

Repeated revascularization Rate at 24 months

Time frame: 24 months

Major Adverse Cardiac Events (MACE) Rate at 12 months

Major Adverse Cardiac Events (MACE) Rate is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization at 12 months

Time frame: 12 months

Major Adverse Cardiac Events (MACE) Rate at 24 months

Major Adverse Cardiac Events (MACE) Rate is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization at 24 months

Time frame: 24 months

Central Contacts

Armando Pérez de Prado, MD, PhD

CONTACT

0034987876135 admin@fundacionepic.org

FUNDACION EPIC

CONTACT

0034987876135 iepic@fundacionepic.org