EucaLimus Post-Market Registry

N/AActive Not RecruitingNCT06621524

OrbusNeich251 enrolled

Overview

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.

The multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (PCI) and are intended to be or treated by the Eucalimus sirolimus eluting PTCA stent (according to the Instructions for Use) as part of routine clinical care. Approximately 251 patients from 5-10 centers in Europe and Asia will be entered into the registry. Patients entered into the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up. A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, and 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.

Study Type

OBSERVATIONAL

Enrollment

251

Conditions

Coronary Arterioscleroses

Interventions

EucaLimus coronary stent systemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Krajska nemocnice Liberec

Liberec, Czechia

Motol University Hospital

Prague, Czechia

Institut Jantung Negara

Kuala Lumpur, Malaysia

Bellvitge University Hospital

Outcomes

Primary Outcomes

Adjudicated, device-oriented, Target Lesion Failure (TLF)

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).

Time frame: 12 months post procedure