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Coronary Artery DiseaseVELAZQUEZNCT04899141

Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Fundación EPIC at 20 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Percutaneous Coronary Intervention
Type of treatment
Medical device
How many people
400 participants
Where
20 sitesin 2 countries
Study dates
29 Oct 2021to 1 May 2028
How long will I take part?
60 Months
Phase
Observational
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

Study population: Patients with all inclusion criteria

Who may be able to join

  • ≥18 years old
  • PCI and stent implantation indication according to ESC Myocardial Revascularization Guidelines
  • 1 or more stenosis at native coronary anatomy, in a 2-4mm vessel size, where 1 or more ihtDEStiny® drug eluting stent were implanted (or attempted to be implanted).
  • Informed consent signed after PCI

Who cannot join

  • Patient refusal to participate in the study
  • Pregnancy
  • Other DES implantation during index PCI, or 30 days before of after index PCI
  • PCI at surgical grafts
  • PCI for in-stent restenosis
  • Killip class 3-4 Acute Coronary Syndromes (ACS)
Show all 11Show fewer
  • High bleeding risk with dual antiplatelet intolerance for at least 3 months (or 6 months for ACS PCI)
  • Allergy or hypersensitivity to sirolimus
  • Patients requiring surgery (cardiac or non-cardiac) in the next 3 months after index PCI
  • Patients with life expectancy <2 years
  • Patients included in other trials or clinical studies

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

Spain19 sites

  • Hospital Universitario de Cruces

    Barakaldo, 48903

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005

  • Hospital Universitario Donostia

    Donostia / San Sebastian, 20014

  • Hospital General Universitario de Elche

    Elche, 03203

  • Hospital de Galdakao

    Galdakao, 48960

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital Universitario Lucus Agusti

    Lugo, 27003

  • Hospital Universitario Regional de Malaga Carlos Haya

    Málaga, Malaga, 29010

  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010

  • Hospital Universitario Virgen Arrixaca

    Murcia, 30120

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario de Araba

    Vitoria-Gasteiz, 01009

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Portugal1 site

  • Centro Hospitalar Universitario Do Algarbe

    Faro, 8000-386

Other trials in Portugal

About this study

Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent.

Read the detailed description

Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent use in real-world percutaneous coronary intervention

Being tested
Percutaneous Coronary Intervention
Keywords
Percutaneous Coronary Intervention, Drug Eluting Stent
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia

What participants receive

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

  • Percutaneous Coronary InterventionDevice

    stenting with the ihtDEStiny® sirolimus eluting stent

Study groups in NCT04899141
Study groupRoleWhat they receive
Coronary Artery DiseaseNot described
Receives: Device: Percutaneous Coronary Intervention

What is being measured

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

  1. Target Lesion Failure (TLF)

    Rate of target lesion failure

    Measured: 2 years

  2. Target Lesion Failure (TLF)

    Rate of target lesion failure

    Measured: 5 years

  3. Death

    Death

    Measured: 2 years

  4. Death

    Death

    Measured: 5 years

  5. Target vessel myocardial infarction

    Target vessel myocardial infarction

    Measured: 2 years

  6. Target vessel myocardial infarction

    Target vessel myocardial infarction

    Measured: 5 years

  7. Target lesion revascularization (TLR)

    Target lesion revascularization (TLR)

    Measured: 2 years

  8. Target lesion revascularization (TLR)

    Target lesion revascularization (TLR)

    Measured: 5 years

  9. Cardiovascular Death

    Cardiovascular Death

    Measured: 2 years

  10. Cardiovascular Death

    Cardiovascular Death

    Measured: 5 years

Secondary outcomes (12)

  1. Stent thrombosis

    Stent thrombosis

    Measured: 2 years

  2. Stent thrombosis

    Stent thrombosis

    Measured: 5 years

  3. Target Vessel Failure (TVF)

    Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR)

    Measured: 2 years

  4. Target Vessel Failure (TVF)

    Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR)

    Measured: 5 years

  5. Major Adverse Cardiovascular Event (MACE)

    Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke

    Measured: 2 years

  6. Major Adverse Cardiovascular Event (MACE)

    Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke

    Measured: 5 years

  7. Patient Oriented Composite Event

    Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization

    Measured: 2 years

  8. Patient Oriented Composite Event

    Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization

    Measured: 5 years

  9. Severe BARC Bleeding

    BARC Bleeding ≥3

    Measured: 2 years

  10. Severe BARC Bleeding

    BARC Bleeding ≥3

    Measured: 5 years

  11. Device success

    residual coronary stenosis<50%, normal coronary flow and absence of coronary dissection ≥C

    Measured: During procedure

  12. Procedural success

    Device success and absence of PCI complication (periprocedural MI, coronary perforation, urgent CABG or death) or revascularization within 3 days

    Measured: 3 days

Timeline

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

  1. First posted24 May 2021
  2. Study start29 Oct 2021
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (actual)
Target duration
60 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04899141
Sponsor's protocol ID
EPIC26-VELAZQUEZ
Acronym
VELAZQUEZ
Status last verified
Feb 2026
First submitted
19 May 2021
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • de la Torre Hernandez JM, Ocaranza Sanchez R, Santas Alvarez M, Pinar Bermudez E, Hurtado Martinez JA, Garcia Del Blanco B, Otaegui I, Fernandez Nofrerias E, Carrillo Suarez X, Sainz Laso F, Casanova Sandoval JM, Rivera Aguilar PK, Cid B, Trillo R, Lozano Ruiz-Poveda F, Peral Disdier V, Telleria M, Torres A, Sanchis J, Oliva X, Freixa X, Sadaba Sagredo M, Moreu J, Hernandez F. Comparison of One-Year Outcomes Between the ihtDEStiny BD Stent and the Durable-Polymer Everolimus- and Zotarolimus-Eluting Stents: A Propensity-Score-Matched Analysis. Cardiovasc Revasc Med. 2021 Oct;31:1-6. doi: 10.1016/j.carrev.2020.09.046. Epub 2020 Oct 3.

    PubMed 33060037

  • 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

  • Buiten RA, Ploumen EH, Zocca P, Doggen CJM, Danse PW, Schotborgh CE, Scholte M, van Houwelingen KG, Stoel MG, Hartmann M, Tjon Joe Gin RM, Somi S, Linssen GCM, Kok MM, von Birgelen C. Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1650-1660. doi: 10.1016/j.jcin.2019.04.054. Epub 2019 Aug 14.

    PubMed 31422087

  • El-Hayek G, Bangalore S, Casso Dominguez A, Devireddy C, Jaber W, Kumar G, Mavromatis K, Tamis-Holland J, Samady H. Meta-Analysis of Randomized Clinical Trials Comparing Biodegradable Polymer Drug-Eluting Stent to Second-Generation Durable Polymer Drug-Eluting Stents. JACC Cardiovasc Interv. 2017 Mar 13;10(5):462-473. doi: 10.1016/j.jcin.2016.12.002.

    PubMed 28279314

  • Iantorno M, Lipinski MJ, Garcia-Garcia HM, Forrestal BJ, Rogers T, Gajanana D, Buchanan KD, Torguson R, Weintraub WS, Waksman R. Meta-Analysis of the Impact of Strut Thickness on Outcomes in Patients With Drug-Eluting Stents in a Coronary Artery. Am J Cardiol. 2018 Nov 15;122(10):1652-1660. doi: 10.1016/j.amjcard.2018.07.040. Epub 2018 Sep 8.

    PubMed 30292330

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Fundación EPIC at 20 sites in 2 countries.

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 4 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 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, Portugal. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure (TLF) (time frame: 2 years). The study lists 10 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 NCT04899141, which also lists 6 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 17 Feb 2026.

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