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 — Not applicable, Recruiting, 2100 participants, Fundación EPIC

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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 (DestinACSion Study)

RegistryNCT07190690, acronym DestinACSion
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment2100 (Estimated)
SponsorFundación EPIC (Other)
ConditionsCoronary Artery Disease
InterventionsihtDEStiny® DES implanted, Xience™ DES implanted (Device)
Datesstart 2025-12-19, primary completion 2029-10-15 (estimated), completion 2030-10-15 (estimated), first posted 2025-09-24, last updated 2026-08-10
Locations20 sites in Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Coronary Artery Disease All trials of ihtDEStiny® DES implanted All trials of Xience™ DES implanted

-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.

Expand all sections  ·  Collapse all

+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Active Comparator: ihtDEStiny® DESOtherDevice: ihtDEStiny® DES implanted
Experimental: Xience™ DESOtherDevice: Xience™ DES implanted
  • ihtDEStiny® DES implanted (Device): ihtDEStiny® DES implanted
  • Xience™ DES implanted (Device): Xience™ DES implanted

+Outcome measures

Primary outcomes

  • EFFICACY: Device-oriented Composite Endpoint (DoCE) [12 months]: Composite clinical endpoint cardiac Rate at 12 months cause death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)
  • NACE [12 months]: Composite clinical endpoint Rate of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events

Secondary outcomes

  • All-Cause Death Rate at 12 months [12 months]: All-Cause Death Rate at 12 months
  • All-Cause Death Rate at 24 months [12 months]: All-Cause Death Rate at 24 months
  • Cardiac Death Rate at 12 months [12 months]: Cardiac Death Rate at 12 months
  • Cardiac Death Rate at 24 months [12 months]: Cardiac Death Rate at 24 months
  • Myocardial Infarction Rate at 12 months [12 months]: Myocardial Infarction Rate at 12 months
  • Myocardial Infarction Rate at 24 months [12 months]: Myocardial Infarction Rate at 24 months
  • Periprocedural myocardial infarction Rate [PCI procedure]: Periprocedural myocardial infarction Rate
  • Definite/Probable stent thrombosis rate at 12 months [12 months]: Definite/Probable stent thrombosis rate at 12 months
  • Definite/Probable stent thrombosis rate at 24 months [24 months]: Definite/Probable stent thrombosis rate at 24 months
  • Any stroke at 12 months [12 months]: Stroke Rate at 12 months
  • Any stroke at 24 months [12 months]: Stroke Rate at 24 months
  • BARC type 2 ,3 or 5 bleeding events at 12 months [12 months]: Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria at 12 months
  • BARC type 2 ,3 or 5 bleeding events at 24 months [24 months]: Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria at 24 months
  • Target vessel revascularization Rate at 12 months [12 months]: Target vessel revascularization Rate at 12 months
  • Target vessel revascularization Rate at 24 months [24 months]: Target vessel revascularization Rate at 24 months
  • Target vessel Failure (TVF) Rate at 12 months [12 months]: Target vessel Failure (TVF) Rate at 12 months
  • Target vessel Failure (TVF) Rate at 24 months [24 months]: Target vessel Failure (TVF) Rate at 24 months
  • Target Lesion Failure (TLF) Rate at 12 months [12 months]: Target Lesion Failure (TLF) Rate at 12 months
  • Target Lesion Failure (TLF) Rate at 24 months [24 months]: Target Lesion Failure (TLF) Rate at 24 months
  • Target Vessel Revascularization Rate (TVR) at 12 months [12 months]: Target Vessel Revascularization Rate (TVR) at 12 months
  • Target Vessel Revascularization Rate (TVR) at 24 months [24 months]: Target Vessel Revascularization Rate (TVR) at 24 months
  • Target lesion ischemia-guided revascularization Rate at 12 months [12 months]: Target lesion ischemia-guided revascularization Rate at 12 months
  • Target lesion ischemia-guided revascularization Rate at 24 months [24 months]: Target lesion ischemia-guided revascularization Rate at 24 months
  • Repeated revascularization Rate at 12 months [12 months]: Repeated revascularization Rate at 12 months
  • Repeated revascularization Rate at 24 months [24 months]: Repeated revascularization Rate at 24 months
  • Major Adverse Cardiac Events (MACE) Rate at 12 months [12 months]: Major Adverse Cardiac Events (MACE) Rate is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization at 12 months
  • Major Adverse Cardiac Events (MACE) Rate at 24 months [24 months]: Major Adverse Cardiac Events (MACE) Rate is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization at 24 months

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (20)

FacilityCityCountryStatus
Hospital Universitario San Juan AlicanteAlicanteSpainRecruiting
Hospital Universitari Germans Trias I PujolBadalonaSpainRecruiting
Hospital Universitario de CrucesBarakaldoSpainRecruiting
Hospital Universitari Vall d'HebronBarcelonaSpainRecruiting
Hospital Clínic de BarcelonaBarcelonaSpainRecruiting
Hospital General Universitario de CastellonCastellóSpainRecruiting
Hospital Universitario de DonostiaDonostia / San SebastianSpainRecruiting
Hospital Universitario Virgen de La ArrixacaEl PalmarSpainRecruiting
Hospital Universitario La PazFuencarral-El PardoSpainRecruiting
Hospital Universitario Juan Ramón JiménezHuelvaSpainRecruiting
Hospital Universitari de BellvitgeL'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario de LeonLeónSpainRecruiting
Hospital Universitari Arnau de VilanovaLleidaSpainRecruiting
Hospital Universitario Lucus AgustíLugoSpainRecruiting
Hospital Regional Universitario de MálagaMálagaSpainRecruiting
Hospital Universitario de CanariasSan Cristóbal de La LagunaSpainRecruiting
Hospital Universitario Marques de ValdecillaSantanderSpainRecruiting
Hospital Clínico Universitario de SantiagoSantiago de CompostelaSpainRecruiting
Hospital Universitari de Tarragona Joan XXIIITarragonaSpainRecruiting
Hospital Clínico Universitario Lozano BlesaZaragozaSpainRecruiting

+Publications

  • 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
  • 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
  • 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
  • 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
  • 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