RecruitingNot Applicable

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

Spain2,100 participantsStarted 2025-12-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing two different drug-coated stents — the ihtDEStiny sirolimus-eluting stent versus the Xience everolimus-eluting stent — so can you explain what the practical difference between these two drugs and their permanent polymer coatings might mean for my recovery and long-term heart health?
2The trial is listed as Phase NA, which isn't a standard numbered phase — can you help me understand what that means for how much safety and effectiveness data already exists for the ihtDEStiny stent compared to what we already know about Xience?
3The trial is measuring something called a Device-oriented Composite Endpoint (DoCE) and NACE — can you walk me through what events those track, like heart attack, repeat procedures, or death, and what that means in terms of what researchers are still trying to learn about these stents?
4Since this trial is specifically for people with Acute Coronary Syndrome and new coronary artery lesions, does my current diagnosis and the specific location or severity of my lesion actually match what this study is looking for?
5Before considering this trial, is there a well-established standard-of-care stenting option you'd recommend for someone in my situation, and how would that compare to the potential unknowns of joining a comparison study like this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

EFFICACY: Device-oriented Composite Endpoint (DoCE)

Timeframe: 12 months

NACE

Timeframe: 12 months

Trial details

NCT IDNCT07190690

SponsorFundación EPIC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-10-15

Contact for this trial

Armando Pérez de Prado, MD, PhD

0034987876135 admin@fundacionepic.org

View on ClinicalTrials.gov More Coronary Artery Disease trials