ihtDEStiny® versus Xience™ drug-eluting stents for acute coronary syndrome
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)
We will see if the ihtDEStiny® sirolimus-eluting stent works as well as the Xience™ everolimus-eluting stent in adults with acute coronary syndrome who need PCI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 13 sites (Alicante and 12 other locations) |
| Trial ID | NCT07190690 on ClinicalTrials.gov |
What this trial studies
Adults with acute coronary syndrome and de novo coronary lesions suitable for drug-eluting stent implantation are enrolled at three Spanish hospitals and receive either the ihtDEStiny® sirolimus-eluting stent or the Xience™ everolimus-eluting stent. The trial compares device-related adverse events and a composite of ischemic and hemorrhagic events (net clinical events) over 12 months after PCI. Clinical and device outcomes are collected during follow-up to compare safety and efficacy between the two permanent-polymer DES. The comparison aims to inform choice of contemporary DES in an ACS population.
Who should consider this trial
Good fit: Adults (≥18 years) with acute coronary syndrome (STEMI or non‑STEMI) who have de novo coronary lesions with vessel diameter 2.25–4.5 mm and can provide informed consent are eligible.
Not a fit: Patients in cardiogenic shock, those unable to provide informed consent, or those with lesions outside the specified size range are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the results could identify a safer or more effective stent option for people with ACS undergoing PCI, potentially reducing complications in the first year.
How similar studies have performed: Other randomized trials have shown modern sirolimus- and everolimus-eluting stents to be effective and safe, so this is an incremental head-to-head comparison rather than a wholly novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Alicante and 12 other locations
- 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)
- Hospital Universitario de Canarias — San Cristóbal de La Laguna, Spain (Recruiting)
- Hospital Clínico Universitario de Santiago — Santiago de Compostela, Spain (Recruiting)
- Hospital Clínico Universitario Lozano Blesa — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: Armando Pérez de Prado, MD, PhD
- Email: admin@fundacionepic.org
- Phone: 0034987876135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.