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

NCT07190690 | Recruiting DMC

• 1 other identifier: EPIC45-DestinACSion
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Drug Eluting Stents

Outcome Measures

Primary Outcomes (2)

• EFFICACY: Device-oriented Composite Endpoint (DoCE)

  Composite clinical endpoint cardiac Rate at 12 months cause death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)

  12 months

• NACE

  Composite clinical endpoint Rate of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events

  12 months

Secondary Outcomes (27)

• All-Cause Death Rate at 12 months

  12 months

• All-Cause Death Rate at 24 months

  12 months

• Cardiac Death Rate at 12 months

  12 months

• Cardiac Death Rate at 24 months

  12 months

• Myocardial Infarction Rate at 12 months

  12 months

Study Arms (2)

Active Comparator: ihtDEStiny® DES

OTHER

Device: ihtDEStiny® DES implanted

Experimental: Xience™ DES

OTHER

Device: Xience™ DES implanted

Interventions

ihtDEStiny® DES implanted DEVICE

ihtDEStiny® DES implanted

Active Comparator: ihtDEStiny® DES

Xience™ DES implanted DEVICE

Xience™ DES implanted

Experimental: Xience™ DES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (13)

Hospital Universitario San Juan Alicante

Alicante, 03550, Spain

RECRUITING

Hospital Universitari Germans Trias I Pujol

Badalona, 08916, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Virgen de La Arrixaca

El Palmar, 30120, Spain

RECRUITING

Hospital Universitario La Paz

Fuencarral-El Pardo, 28046, Spain

RECRUITING

Hospital Universitario Juan Ramón Jiménez

Huelva, 21005, Spain

RECRUITING

Hospital Universitario de Leon

León, 24008, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

Hospital Universitario Lucus Agustí

Lugo, 27003, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, 38320, Spain

RECRUITING

Hospital Clínico Universitario de Santiago

Santiago de Compostela, 15706, Spain

RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

RECRUITING

Related Publications (5)

• de la Torre Hernandez JM, Otaegui I, Subinas A, Gomez-Menchero A, Moreno R, Rondan J, Munoz-Garcia E, Sainz-Laso F, Garcia Del Blanco B, Rumoroso JR, Diaz JF, Berenguer A, Gomez-Lara J, Zueco J. First-in-Man Evaluation of a Sirolimus-Eluting Stent With Abluminal Fluoropolymeric/Triflusal Coating With Ultrathin Struts by OCT at 9 Months' Follow-Up: The PROMETHEUS Study. Cardiovasc Revasc Med. 2021 Nov;32:18-24. doi: 10.1016/j.carrev.2020.12.025. Epub 2020 Dec 29.

  PMID: 33386256 BACKGROUND

• Ploumen EH, von Birgelen C. Novel DES Aims at Full Thromboresistance: Another Promising Player on the Field? Cardiovasc Revasc Med. 2021 Nov;32:25-26. doi: 10.1016/j.carrev.2021.07.029. Epub 2021 Aug 11. No abstract available.

  PMID: 34391680 BACKGROUND

• Linares Vicente JA, Sainz Laso F, Casanova Sandoval JM, Rumoroso Cueva JR, Gomez Menchero A, Gomez Hospital JA, Perez Guerrero A, Santos Martinez S, Fernandez Portales J, Romani S, Garcia Del Blanco B, Ocaranza Sanchez R, Urbano Carrillo C, Garcia San Roman K, Vinhas H, Cid Alvarez B, Sanchis Fores J, Telleria Arrieta M, Torres Bosco A, Pinar Bermudez E, Mendez Castro JJ, Lozano Ruiz de Poveda F, Perez de Prado A, De la Torre Hernandez JM. Long-term outcomes of hydrodynamic ultra-thin strut sirolimus-eluting stent with fluoropolymer containing triflusal: VELAZQUEZ-EPIC26 study. Cardiovasc Revasc Med. 2026 Mar;84:26-33. doi: 10.1016/j.carrev.2025.07.009. Epub 2025 Jul 17.

  PMID: 40713212 BACKGROUND

• Zaman A, de Winter RJ, Kogame N, Chang CC, Modolo R, Spitzer E, Tonino P, Hofma S, Zurakowski A, Smits PC, Prokopczuk J, Moreno R, Choudhury A, Petrov I, Cequier A, Kukreja N, Hoye A, Iniguez A, Ungi I, Serra A, Gil RJ, Walsh S, Tonev G, Mathur A, Merkely B, Colombo A, Ijsselmuiden S, Soliman O, Kaul U, Onuma Y, Serruys PW; TALENT trial investigators. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet. 2019 Mar 9;393(10175):987-997. doi: 10.1016/S0140-6736(18)32467-X. Epub 2019 Feb 28.

  PMID: 30827782 BACKGROUND

• Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

  PMID: 29891620 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Armando Pérez de Prado, MD, PhD

CONTACT

0034987876135; admin@fundacionepic.org

FUNDACION EPIC

CONTACT

0034987876135; iepic@fundacionepic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): October 15, 2029
• Study Completion (Estimated): October 15, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

ES (13)