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Clinical Trials in Czechia / NCT06621524
Active, not recruiting Observational

EucaLimus Post-Market Registry

NCT06621524 · tracked via the Priya Life Science Czechia tracker
Sponsor
OrbusNeich
Phase
Observational
Started
2025-03-14
Last updated
2026-03-11

Condition(s) studied

Coronary Arterioscleroses

Investigational drug(s) / intervention(s)

EucaLimus coronary stent system

EucaLimus coronary stent system: The EucaLimus coronary stent system is a drug-coated coronary stent system, indicated for use in patients with symptomatic ischaemic coronary heart disease due to de novo lesions or restenosed lesions of the coronary arteries.

Study summary

To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the Eucalimus sirolimus eluting PTCA stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Eucalimus PTCA stent in routine clinical practice.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Consecutive patients intended to be, or treated by EucaLimus as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry. Exclusion Criteria: * Patients are excluded from registration if ANY of the following conditions apply: * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned * A life expectancy of \<1year * Explicit refusal of participation in the registry

Primary outcome measure(s)

  • Adjudicated, device-oriented, Target Lesion Failure (TLF) — 12 months post procedure
    Adjudicated, device-oriented, Target Lesion Failure (TLF) where TLF is defined (Academic Research Consortium- ARC) as a composite of cardiac death (CD), non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel (TV-MI) or clinically driven target lesion revascularization (cd-TLR).

Trial sites (10)

FacilityCityRegionStatus
Krajska nemocnice Liberec Liberec Czechia
Motol University Hospital Prague Czechia
Institut Jantung Negara Kuala Lumpur Malaysia
Bellvitge University Hospital L'Hospitalet de Llobregat Catalonia
Hospital de la Santa Creu i Sant Pau Barcelona Spain
Hospital Universitario Vall d'Hebron Barcelona Spain
Hospital Universitario Reina Sofía Córdoba Spain
Hospital Universitario Lucus Augusti Lugo Spain
Complejo Hospitalario Universitario de Canarias San Cristóbal de La Laguna Spain
Hospital Universitario Joan XXIII Tarragona Spain

More OrbusNeich trials in Czechia

Support C Post-Market Registry 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 NCT06621524 on ClinicalTrials.gov ↗ ← All trials in Czechia