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NCT Number: 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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario San Juan Alicante, Alicante, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ihtDEStiny® DES implanted

Device

ihtDEStiny® DES implanted

Xience™ DES implanted

Device

Xience™ DES implanted

Primary outcomes

  1. EFFICACY: Device-oriented Composite Endpoint (DoCE)

    Time frame: 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)

  2. NACE

    Time frame: 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

  1. All-Cause Death Rate at 12 months

    Time frame: 12 months

    All-Cause Death Rate at 12 months

  2. All-Cause Death Rate at 24 months

    Time frame: 12 months

    All-Cause Death Rate at 24 months

  3. Cardiac Death Rate at 12 months

    Time frame: 12 months

    Cardiac Death Rate at 12 months

  4. Cardiac Death Rate at 24 months

    Time frame: 12 months

    Cardiac Death Rate at 24 months

  5. Myocardial Infarction Rate at 12 months

    Time frame: 12 months

    Myocardial Infarction Rate at 12 months

  6. Myocardial Infarction Rate at 24 months

    Time frame: 12 months

    Myocardial Infarction Rate at 24 months

  7. Periprocedural myocardial infarction Rate

    Time frame: PCI procedure

    Periprocedural myocardial infarction Rate

  8. Definite/Probable stent thrombosis rate at 12 months

    Time frame: 12 months

    Definite/Probable stent thrombosis rate at 12 months

  9. Definite/Probable stent thrombosis rate at 24 months

    Time frame: 24 months

    Definite/Probable stent thrombosis rate at 24 months

  10. Any stroke at 12 months

    Time frame: 12 months

    Stroke Rate at 12 months

  11. Any stroke at 24 months

    Time frame: 12 months

    Stroke Rate at 24 months

  12. BARC type 2 ,3 or 5 bleeding events at 12 months

    Time frame: 12 months

    Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria at 12 months

  13. BARC type 2 ,3 or 5 bleeding events at 24 months

    Time frame: 24 months

    Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria at 24 months

  14. Target vessel revascularization Rate at 12 months

    Time frame: 12 months

    Target vessel revascularization Rate at 12 months

  15. Target vessel revascularization Rate at 24 months

    Time frame: 24 months

    Target vessel revascularization Rate at 24 months

  16. Target vessel Failure (TVF) Rate at 12 months

    Time frame: 12 months

    Target vessel Failure (TVF) Rate at 12 months

  17. Target vessel Failure (TVF) Rate at 24 months

    Time frame: 24 months

    Target vessel Failure (TVF) Rate at 24 months

  18. Target Lesion Failure (TLF) Rate at 12 months

    Time frame: 12 months

    Target Lesion Failure (TLF) Rate at 12 months

  19. Target Lesion Failure (TLF) Rate at 24 months

    Time frame: 24 months

    Target Lesion Failure (TLF) Rate at 24 months

  20. Target Vessel Revascularization Rate (TVR) at 12 months

    Time frame: 12 months

    Target Vessel Revascularization Rate (TVR) at 12 months

  21. Target Vessel Revascularization Rate (TVR) at 24 months

    Time frame: 24 months

    Target Vessel Revascularization Rate (TVR) at 24 months

  22. Target lesion ischemia-guided revascularization Rate at 12 months

    Time frame: 12 months

    Target lesion ischemia-guided revascularization Rate at 12 months

  23. Target lesion ischemia-guided revascularization Rate at 24 months

    Time frame: 24 months

    Target lesion ischemia-guided revascularization Rate at 24 months

  24. Repeated revascularization Rate at 12 months

    Time frame: 12 months

    Repeated revascularization Rate at 12 months

  25. Repeated revascularization Rate at 24 months

    Time frame: 24 months

    Repeated revascularization Rate at 24 months

  26. Major Adverse Cardiac Events (MACE) Rate at 12 months

    Time frame: 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

  27. Major Adverse Cardiac Events (MACE) Rate at 24 months

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Armando Pérez de Prado, MD, PhD

CONTACT

[email protected]

0034987876135

FUNDACION EPIC

CONTACT

[email protected]

0034987876135

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study 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 (DestinACSion Study)

Acronym: DestinACSion

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Sep 24, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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