ihtDEStiny® versus Xience™ drug-eluting stents for acute coronary syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Universitario San Juan Alicante
  Alicante, Spain Recruiting
• Hospital Universitari Germans Trias I Pujol
  Badalona, Spain Recruiting
• Hospital Universitario de Cruces
  Barakaldo, Spain Recruiting
• Hospital Universitari Vall d'Hebron
  Barcelona, Spain Recruiting
• Hospital Clínic de Barcelona
  Barcelona, Spain Recruiting
• Hospital General Universitario de Castellon
  Castelló, Spain Recruiting

Study contacts

• Study coordinator: Armando Pérez de Prado, MD, PhD
• Email: admin@fundacionepic.org
• Phone: 0034987876135

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.