Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07190690

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

Led by Fundación EPIC · Updated on 2026-04-13

2100

Participants Needed

13

Research Sites

251 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 65 years or older
  • Diagnosed with acute coronary syndrome (either SCASEST or IAMCEST) and planned to undergo PCI
  • Have de novo lesions in vessels with a diameter between 2.25 mm and 4.5 mm requiring implantation of one or more DES
  • Provided written informed consent after being informed about the study
Not Eligible

You will not qualify if you...

  • Patients in cardiogenic shock classified as "C", "D", or "E" by SCAI criteria
  • Unable to provide informed consent
  • Known allergy or hypersensitivity to aspirin, P2Y12 receptor inhibitors, heparin, contrast agents, or DES components
  • Active bleeding at the time of PCI needing medical attention
  • Planned surgery within the next 3 months
  • Medical conditions limiting life expectancy to less than 12 months
  • Participating in another clinical trial with unmet primary endpoint
  • Pregnant or breastfeeding women with positive pregnancy test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

Hospital Universitario San Juan Alicante

Alicante, Spain, 03550

Actively Recruiting

2

Hospital Universitari Germans Trias I Pujol

Badalona, Spain, 08916

Actively Recruiting

3

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

4

Hospital Universitario Virgen de La Arrixaca

El Palmar, Spain, 30120

Actively Recruiting

5

Hospital Universitario La Paz

Fuencarral-El Pardo, Spain, 28046

Actively Recruiting

6

Hospital Universitario Juan Ramón Jiménez

Huelva, Spain, 21005

Actively Recruiting

7

Hospital Universitario de Leon

León, Spain, 24008

Actively Recruiting

8

Hospital Universitari Arnau de Vilanova

Lleida, Spain, 25198

Actively Recruiting

9

Hospital Universitario Lucus Agustí

Lugo, Spain, 27003

Actively Recruiting

10

Hospital Regional Universitario de Málaga

Málaga, Spain, 29010

Actively Recruiting

11

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain, 38320

Actively Recruiting

12

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain, 15706

Actively Recruiting

13

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain, 50009

Actively Recruiting

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Research Team

A

Armando Pérez de Prado, MD, PhD

CONTACT

F

FUNDACION EPIC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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