RecruitingNot ApplicableNCT07190690

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

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 Study)


Sponsor

Fundación EPIC

Enrollment

2,100 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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.

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Interventions

DEVICEihtDEStiny® DES implanted

ihtDEStiny® DES implanted

DEVICEXience™ DES implanted

Xience™ DES implanted


Locations(12)

Hospital Universitario San Juan Alicante

Alicante, Spain

Hospital Universitari Germans Trias I Pujol

Badalona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Virgen de La Arrixaca

El Palmar, Spain

Hospital Universitario La Paz

Fuencarral-El Pardo, Spain

Hospital Universitario Juan Ramón Jiménez

Huelva, Spain

Hospital Universitario de Leon

León, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Hospital Universitario Lucus Agustí

Lugo, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

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NCT07190690


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