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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ihtDEStiny® DES implanted
  • Xience™ DES implanted

Treatment groups

2,100 Participants
are divided into 2 treatment groups

Locations

17
Hospital Universitario San Juan Alicante03550, Alicante Spain
Hospital Universitari Germans Trias I Pujol08916, Badalona Spain
Hospital Universitario de Cruces48903, Barakaldo Spain
Hospital Universitari Vall d'Hebron08035, Barcelona Spain

Sponsors and collaborators

Fundación EPIC

Lead sponsor