Status:
RECRUITING
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
Lead Sponsor:
Fundación EPIC
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2030
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT07190690
Start Date
December 19 2025
End Date
October 15 2030
Last Update
January 9 2026
Active Locations (3)
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1
Hospital Universitari Germans Trias I Pujol
Badalona, Spain, 08916
2
Hospital Universitario de Leon
León, Spain, 24008
3
Hospital Universitario Lucus Agustí
Lugo, Spain, 27003