Actively Recruiting
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
Eligibility Criteria
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
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
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
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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