EucaLimus Post-Market Registry

NCT06621524 | Active Not Recruiting

• 1 other identifier: DVAL-PLAN-0062
• Study Type: observational
• Target: 251
• Locations: 3 countries
• Sites: 10

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.

Conditions

Coronary Arterioscleroses

Keywords

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Cardiovascular Diseases; Drug-Coated Stent; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months post procedure

Secondary Outcomes (9)

• Adjudicated Target Lesion Failure (TLF)

  through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months

• 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))

  through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months

• Adjudicated Target Vessel Failure (TVF) (ARC definition) as a composite of Cardiovascular Death (CVD), TV-MI and clinically driven target vessel revascularization (cd-TVR)

  through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months

• Each of the components of TVF (Cardiovascular Death (CVD), TV-MI and clinically driven target vessel revascularization (cd-TVR))

  through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months

• Adjudicated stent thrombosis per ARC-2 definition

  through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months

Study Arms (1)

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.

Device: EucaLimus coronary stent system

Interventions

EucaLimus coronary stent system DEVICE

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.

Device: EucaLimus coronary stent system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eucatech AG: collaborator
• OrbusNeich: lead
• Centre Européen de Recherche Cardiovasculaire: collaborator

Study Sites (10)

Krajska nemocnice Liberec

Liberec, 46001, Czechia

Location

Motol University Hospital

Prague, 15006, Czechia

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Bellvitge University Hospital

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Complejo Hospitalario Universitario de Canarias

San Cristóbal de La Laguna, 38320, Spain

Location

Hospital Universitario Joan XXIII

Tarragona, 43005, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Josep Gomez-Lara, MD, PhD

  Bellvitge University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: March 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1); ES (7); CZ (2)