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Coronary Artery DiseaseDestinACSionNCT07190690

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

A study testing ihtDEStiny® DES implanted and Xience™ DES implanted in people with Coronary Artery Disease, run by Fundación EPIC at 20 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
ihtDEStiny® DES implanted and Xience™ DES implanted
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,100 participants
Where
20 sitesSpain
Study dates
19 Dec 2025to 15 Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Armando Pérez de Prado, MD, PhD contact

0034987876135

admin@fundacionepic.org

20 sites in 1 country

Spain20 sites, 20 recruiting
  • Hospital Universitario San Juan Alicante

    Alicante, 03550

    Recruiting
  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916

    Recruiting
  • Hospital Universitario de Cruces

    Barakaldo, 48903

    Recruiting
  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Recruiting
  • Hospital Clínic de Barcelona

    Barcelona, 08036

    Recruiting
  • Hospital General Universitario de Castellon

    Castelló, 12004

    Recruiting
  • Hospital Universitario de Donostia

    Donostia / San Sebastian, 20014

    Recruiting
  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, 30120

    Recruiting
  • Hospital Universitario La Paz

    Fuencarral-El Pardo, 28046

    Recruiting
  • Hospital Universitario Juan Ramón Jiménez

    Huelva, 21005

    Recruiting
  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

    Recruiting
  • Hospital Universitario de Leon

    León, 24008

    Recruiting
  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

    Recruiting
  • Hospital Universitario Lucus Agustí

    Lugo, 27003

    Recruiting
  • Hospital Regional Universitario de Málaga

    Málaga, 29010

    Recruiting
  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

    Recruiting
  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

    Recruiting
  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, 15706

    Recruiting
  • Hospital Universitari de Tarragona Joan XXIII

    Tarragona, 43005

    Recruiting
  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

    Recruiting

Other trials in Spain

About this study

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 (DestinACSion 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.

Read the 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.

Being tested
ihtDEStiny® DES implanted, Xience™ DES implanted
Keywords
Drug Eluting Stents
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ihtDEStiny® DES implantedDevice

    ihtDEStiny® DES implanted

  • Xience™ DES implantedDevice

    Xience™ DES implanted

Study groups in NCT07190690
Study groupRoleWhat they receive
Active Comparator: ihtDEStiny® DESOtherNot described
Receives: Device: ihtDEStiny® DES implanted
Experimental: Xience™ DESOtherNot described
Receives: Device: Xience™ DES implanted

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 12 months

  2. NACE

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

    Measured: 12 months

Secondary outcomes (27)
  1. All-Cause Death Rate at 12 months

    All-Cause Death Rate at 12 months

    Measured: 12 months

  2. All-Cause Death Rate at 24 months

    All-Cause Death Rate at 24 months

    Measured: 12 months

  3. Cardiac Death Rate at 12 months

    Cardiac Death Rate at 12 months

    Measured: 12 months

  4. Cardiac Death Rate at 24 months

    Cardiac Death Rate at 24 months

    Measured: 12 months

  5. Myocardial Infarction Rate at 12 months

    Myocardial Infarction Rate at 12 months

    Measured: 12 months

  6. Myocardial Infarction Rate at 24 months

    Myocardial Infarction Rate at 24 months

    Measured: 12 months

  7. Periprocedural myocardial infarction Rate

    Periprocedural myocardial infarction Rate

    Measured: PCI procedure

  8. Definite/Probable stent thrombosis rate at 12 months

    Definite/Probable stent thrombosis rate at 12 months

    Measured: 12 months

  9. Definite/Probable stent thrombosis rate at 24 months

    Definite/Probable stent thrombosis rate at 24 months

    Measured: 24 months

  10. Any stroke at 12 months

    Stroke Rate at 12 months

    Measured: 12 months

  11. Any stroke at 24 months

    Stroke Rate at 24 months

    Measured: 12 months

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

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

    Measured: 12 months

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

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

    Measured: 24 months

  14. Target vessel revascularization Rate at 12 months

    Target vessel revascularization Rate at 12 months

    Measured: 12 months

  15. Target vessel revascularization Rate at 24 months

    Target vessel revascularization Rate at 24 months

    Measured: 24 months

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

    Target vessel Failure (TVF) Rate at 12 months

    Measured: 12 months

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

    Target vessel Failure (TVF) Rate at 24 months

    Measured: 24 months

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

    Target Lesion Failure (TLF) Rate at 12 months

    Measured: 12 months

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

    Target Lesion Failure (TLF) Rate at 24 months

    Measured: 24 months

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

    Target Vessel Revascularization Rate (TVR) at 12 months

    Measured: 12 months

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

    Target Vessel Revascularization Rate (TVR) at 24 months

    Measured: 24 months

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

    Target lesion ischemia-guided revascularization Rate at 12 months

    Measured: 12 months

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

    Target lesion ischemia-guided revascularization Rate at 24 months

    Measured: 24 months

  24. Repeated revascularization Rate at 12 months

    Repeated revascularization Rate at 12 months

    Measured: 12 months

  25. Repeated revascularization Rate at 24 months

    Repeated revascularization Rate at 24 months

    Measured: 24 months

  26. Major Adverse Cardiac Events (MACE) Rate at 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

    Measured: 12 months

  27. Major Adverse Cardiac Events (MACE) Rate at 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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start19 Dec 2025
  3. Primary completion15 Oct 2029 (estimated)
  4. Study completion15 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07190690
Sponsor's protocol ID
EPIC45-DestinACSion
Acronym
DestinACSion
Status last verified
Aug 2026
First submitted
17 Sep 2025
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 29891620

Questions about this trial

What is this clinical trial studying?

A study testing ihtDEStiny® DES implanted and Xience™ DES implanted in people with Coronary Artery Disease, run by Fundación EPIC at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Armando Pérez de Prado, MD, PhD (0034987876135, admin@fundacionepic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EFFICACY: Device-oriented Composite Endpoint (DoCE) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07190690, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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