Coronary Artery Disease
Conditions
Keywords
Drug Eluting Stents
Brief summary
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.
Detailed 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.
Interventions
DEVICEihtDEStiny® DES implanted
ihtDEStiny® DES implanted
DEVICEXience™ DES implanted
Xience™ DES implanted
Sponsors
Fundación EPIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EFFICACY: Device-oriented Composite Endpoint (DoCE) | 12 months | Composite clinical endpoint cardiac Rate at 12 months cause death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR) |
| NACE | 12 months | Composite clinical endpoint Rate of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Death Rate at 12 months | 12 months | All-Cause Death Rate at 12 months |
| All-Cause Death Rate at 24 months | 12 months | All-Cause Death Rate at 24 months |
| Cardiac Death Rate at 12 months | 12 months | Cardiac Death Rate at 12 months |
| Cardiac Death Rate at 24 months | 12 months | Cardiac Death Rate at 24 months |
| Myocardial Infarction Rate at 12 months | 12 months | Myocardial Infarction Rate at 12 months |
| Myocardial Infarction Rate at 24 months | 12 months | Myocardial Infarction Rate at 24 months |
| Periprocedural myocardial infarction Rate | PCI procedure | Periprocedural myocardial infarction Rate |
| Definite/Probable stent thrombosis rate at 12 months | 12 months | Definite/Probable stent thrombosis rate at 12 months |
| Definite/Probable stent thrombosis rate at 24 months | 24 months | Definite/Probable stent thrombosis rate at 24 months |
| Any stroke at 12 months | 12 months | Stroke Rate at 12 months |
| Any stroke at 24 months | 12 months | Stroke Rate at 24 months |
| BARC type 2 ,3 or 5 bleeding events at 12 months | 12 months | Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria at 12 months |
| BARC type 2 ,3 or 5 bleeding events at 24 months | 24 months | Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria at 24 months |
| Target vessel revascularization Rate at 12 months | 12 months | Target vessel revascularization Rate at 12 months |
| Target vessel revascularization Rate at 24 months | 24 months | Target vessel revascularization Rate at 24 months |
| Target vessel Failure (TVF) Rate at 12 months | 12 months | Target vessel Failure (TVF) Rate at 12 months |
| Target vessel Failure (TVF) Rate at 24 months | 24 months | Target vessel Failure (TVF) Rate at 24 months |
| Target Lesion Failure (TLF) Rate at 12 months | 12 months | Target Lesion Failure (TLF) Rate at 12 months |
| Target Lesion Failure (TLF) Rate at 24 months | 24 months | Target Lesion Failure (TLF) Rate at 24 months |
| Target Vessel Revascularization Rate (TVR) at 12 months | 12 months | Target Vessel Revascularization Rate (TVR) at 12 months |
| Target Vessel Revascularization Rate (TVR) at 24 months | 24 months | Target Vessel Revascularization Rate (TVR) at 24 months |
| Target lesion ischemia-guided revascularization Rate at 12 months | 12 months | Target lesion ischemia-guided revascularization Rate at 12 months |
| Target lesion ischemia-guided revascularization Rate at 24 months | 24 months | Target lesion ischemia-guided revascularization Rate at 24 months |
| Repeated revascularization Rate at 12 months | 12 months | Repeated revascularization Rate at 12 months |
| Repeated revascularization Rate at 24 months | 24 months | Repeated revascularization Rate at 24 months |
| Major Adverse Cardiac Events (MACE) Rate at 12 months | 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 |
| Major Adverse Cardiac Events (MACE) Rate at 24 months | 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 |
Countries
Spain
Contacts
CONTACTArmando Pérez de Prado, MD, PhD
CONTACTFUNDACION EPIC
Outcome results
None listed