Clinical trial NCT06621524: EucaLimus Post-Market Registry
Official title: Coronary Angioplasty With Sirolimus Drug-coated Stent System to Treat Patients With Symptomatic Ischemic Coronary Heart Disease: a PMCF Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Arterioscleroses
Keywords: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Cardiovascular Diseases
Drug-Coated Stent
Ischemic Heart Disease
Lead sponsor: OrbusNeich
Sponsor class: INDUSTRY
Collaborators: name: Eucatech AG
name: Centre Européen de Recherche Cardiovasculaire
First posted: 2024-10-01
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic ischaemic coronary heart disease due to de novo lesions or restenosis lesions of the coronary arteries, or patients with acute or suspected occlusions who responded unsuccessfully to an interventional therapy following balloon dilatation.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Adjudicated, device-oriented, Target Lesion Failure (TLF)
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Adjudicated Target Lesion Failure (TLF)
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Each of the components of TLF (Cardiac Death (CD), non-fatal myocardial infarction not clearly attributable to a non-target vessel (TV-MI), clinically driven target lesion revascularization (cd-TLR))
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Adjudicated Target Vessel Failure (TVF) (ARC definition) as a composite of Cardiovascular Death (CVD), TV-MI and clinically driven target vessel revascularization (cd-TVR)
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Each of the components of TVF (Cardiovascular Death (CVD), TV-MI and clinically driven target vessel revascularization (cd-TVR))
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Adjudicated stent thrombosis per ARC-2 definition
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Adjudicated bleeding Type 3-5 per the Bleeding Academic Research Consortium (BARC) definition
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Adjudicated stroke
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Device success
timeFrame: Index Procedure
measure: Procedure Success
timeFrame: Index Procedure
Other outcomes:
Locations:
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec
city: Prague
country: Czechia
facility: Motol University Hospital
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: L'Hospitalet de Llobregat
country: Spain
facility: Bellvitge University Hospital
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
Study officials:
affiliation: Bellvitge University Hospital
name: Josep Gomez-Lara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: