Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice (VELAZQUEZ)

February 12, 2026 updated by: Fundación EPIC
Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Portugal
      • Faro, Portugal, 8000-386
        • Centro Hospitalar Universitario Do Algarbe
  • Spain
      • Barakaldo, Spain, 48903
        • Hospital Universitario de Cruces
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Ciudad Real, Spain, 13005
        • Hospital General Universitario de Ciudad Real
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Donostia / San Sebastian, Spain, 20014
        • Hospital Universitario Donostia
      • Elche, Spain, 03203
        • Hospital General Universitario de Elche
      • Galdakao, Spain, 48960
        • Hospital de Galdakao
      • Huelva, Spain, 21005
        • Hospital Universitario Juan Ramon Jimenez
      • L'Hospitalet de Llobregat, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Lleida, Spain, 25198
        • Hospital Universitari Arnau de Vilanova de Lleida
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Agustí
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen Arrixaca
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Santiago de Compostela, Spain, 15706
        • Hospital Clinico Universitario Santiago de Compostela
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Vitoria-Gasteiz, Spain, 01009
        • Hospital Universitario de Araba
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Hospital Universitario Regional de Malaga Carlos Haya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with all inclusion criteria

Description

Inclusion Criteria:

  • ≥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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Coronary Artery Disease
Device: Percutaneous Coronary Intervention
stenting with the ihtDEStiny® sirolimus eluting stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF)
Time Frame: 2 years
Rate of target lesion failure
2 years
Death
Time Frame: 2 years
Death
2 years
Target vessel myocardial infarction
Time Frame: 2 years
Target vessel myocardial infarction
2 years
Target lesion revascularization (TLR)
Time Frame: 2 years
Target lesion revascularization (TLR)
2 years
Cardiovascular Death
Time Frame: 2 years
Cardiovascular Death
2 years
Death
Time Frame: 5 years
Death
5 years
Target Lesion Failure (TLF)
Time Frame: 5 years
Rate of target lesion failure
5 years
Target vessel myocardial infarction
Time Frame: 5 years
Target vessel myocardial infarction
5 years
Target lesion revascularization (TLR)
Time Frame: 5 years
Target lesion revascularization (TLR)
5 years
Cardiovascular Death
Time Frame: 5 years
Cardiovascular Death
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stent thrombosis
Time Frame: 2 years
Stent thrombosis
2 years
Target Vessel Failure (TVF)
Time Frame: 2 years
Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR)
2 years
Major Adverse Cardiovascular Event (MACE)
Time Frame: 2 years
Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke
2 years
Patient Oriented Composite Event
Time Frame: 2 years
Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization
2 years
Severe BARC Bleeding
Time Frame: 2 years
BARC Bleeding ≥3
2 years
Device success
Time Frame: During procedure
residual coronary stenosis<50%, normal coronary flow and absence of coronary dissection ≥C
During procedure
Procedural success
Time Frame: 3 days
Device success and absence of PCI complication (periprocedural MI, coronary perforation, urgent CABG or death) or revascularization within 3 days
3 days
Stent thrombosis
Time Frame: 5 years
Stent thrombosis
5 years
Target Vessel Failure (TVF)
Time Frame: 5 years
Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR)
5 years
Major Adverse Cardiovascular Event (MACE)
Time Frame: 5 years
Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke
5 years
Patient Oriented Composite Event
Time Frame: 5 years
Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization
5 years
Severe BARC Bleeding
Time Frame: 5 years
BARC Bleeding ≥3
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPIC26-VELAZQUEZ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Percutaneous Coronary Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings