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ACTIVE NOT RECRUITING
NCT06621524

EucaLimus Post-Market Registry

Sponsor: OrbusNeich

View on ClinicalTrials.gov

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.

Official title: Coronary Angioplasty With Sirolimus Drug-coated Stent System to Treat Patients With Symptomatic Ischemic Coronary Heart Disease: a PMCF Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

251

Start Date

2025-03-14

Completion Date

2029-01

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (10)

Krajska nemocnice Liberec

Liberec, Czechia

Motol University Hospital

Prague, Czechia

Institut Jantung Negara

Kuala Lumpur, Malaysia

Bellvitge University Hospital

L'Hospitalet de Llobregat, Catalonia, Spain

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