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Active, Not Recruiting

NCT Number: NCT04899141

Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar Universitario Do Algarbe, Faro, Portugal

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Percutaneous coronary intervention

Device

stenting with the ihtDEStiny® sirolimus eluting stent

Primary outcomes

  1. Target Lesion Failure (TLF)

    Time frame: 2 years

    Rate of target lesion failure

  2. Target Lesion Failure (TLF)

    Time frame: 5 years

    Rate of target lesion failure

  3. Death

    Time frame: 2 years

    Death

  4. Death

    Time frame: 5 years

    Death

  5. Target vessel myocardial infarction

    Time frame: 2 years

    Target vessel myocardial infarction

  6. Target vessel myocardial infarction

    Time frame: 5 years

    Target vessel myocardial infarction

  7. Target lesion revascularization (TLR)

    Time frame: 2 years

    Target lesion revascularization (TLR)

  8. Target lesion revascularization (TLR)

    Time frame: 5 years

    Target lesion revascularization (TLR)

  9. Cardiovascular Death

    Time frame: 2 years

    Cardiovascular Death

  10. Cardiovascular Death

    Time frame: 5 years

    Cardiovascular Death

Secondary outcomes

  1. Stent thrombosis

    Time frame: 2 years

    Stent thrombosis

  2. Stent thrombosis

    Time frame: 5 years

    Stent thrombosis

  3. Target Vessel Failure (TVF)

    Time frame: 2 years

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

  4. 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. Major Adverse Cardiovascular Event (MACE)

    Time frame: 2 years

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

  6. Major Adverse Cardiovascular Event (MACE)

    Time frame: 5 years

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

  7. Patient Oriented Composite Event

    Time frame: 2 years

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

  8. Patient Oriented Composite Event

    Time frame: 5 years

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

  9. Severe BARC Bleeding

    Time frame: 2 years

    BARC Bleeding ≥3

  10. Severe BARC Bleeding

    Time frame: 5 years

    BARC Bleeding ≥3

  11. Device success

    Time frame: During procedure

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

  12. 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

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Acronym: VELAZQUEZ

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 24, 2021
Registry last updated
Feb 17, 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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