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Clinical Trials in Spain / NCT04899141
Active, not recruiting Observational

Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

NCT04899141 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación EPIC
Phase
Observational
Started
2021-10-29
Last updated
2026-02-17

Condition(s) studied

Coronary Artery DiseaseIschemic Heart Disease

Investigational drug(s) / intervention(s)

Percutaneous Coronary Intervention

Percutaneous Coronary Intervention: stenting with the ihtDEStiny® sirolimus eluting stent

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Target Lesion Failure (TLF) — 2 years
    Rate of target lesion failure
  • Target Lesion Failure (TLF) — 5 years
    Rate of target lesion failure
  • Death — 2 years
    Death
  • Death — 5 years
    Death
  • Target vessel myocardial infarction — 2 years
    Target vessel myocardial infarction
  • Target vessel myocardial infarction — 5 years
    Target vessel myocardial infarction
  • Target lesion revascularization (TLR) — 2 years
    Target lesion revascularization (TLR)
  • Target lesion revascularization (TLR) — 5 years
    Target lesion revascularization (TLR)
  • Cardiovascular Death — 2 years
    Cardiovascular Death
  • Cardiovascular Death — 5 years
    Cardiovascular Death

Trial sites (20)

FacilityCityRegionStatus
Centro Hospitalar Universitario Do Algarbe Faro Portugal
Hospital Universitario Regional de Malaga Carlos Haya Málaga Malaga
Hospital Universitario de Cruces Barakaldo Spain
Hospital Universitari Vall D'Hebron Barcelona Spain
Hospital San Pedro de Alcantara Cáceres Spain
Hospital General Universitario de Ciudad Real Ciudad Real Spain
Hospital Universitario Donostia Donostia / San Sebastian Spain
Hospital General Universitario de Elche Elche Spain
Hospital de Galdakao Galdakao Spain
Hospital Universitario Juan Ramon Jimenez Huelva Spain
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Spain
Hospital Universitari Arnau de Vilanova de Lleida Lleida Spain
Hospital Universitario Lucus Agusti Lugo Spain
Hospital Universitario Virgen de La Victoria Málaga Spain
Hospital Universitario Virgen Arrixaca Murcia Spain
Hospital Universitario Marques de Valdecilla Santander Spain
Hospital Clinico Universitario Santiago de Compostela Santiago de Compostela Spain
Hospital Clinico Universitario de Valencia Valencia Spain
Hospital Universitario de Araba Vitoria-Gasteiz Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain

More Fundación EPIC trials in Spain

Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR Active, not recruiting
Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial Active, not recruiting
Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation Active, not recruiting
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients Active, not recruiting
ANGiographic Evaluation of Left Main Coronary Artery INtErvention Active, not recruiting

Other trials for the same condition

Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR Active, not recruiting
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events Active, not recruiting
Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial Active, not recruiting
Randomization of Single vs Multiple Arterial Grafts Recruiting
Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04899141 on ClinicalTrials.gov ↗ ← All trials in Spain