EucaLimus Post-Market Registry

Last updated: April 25, 2025
Sponsor: OrbusNeich
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Coronary Artery Disease

Thrombosis

Treatment

EucaLimus coronary stent system

Clinical Study ID

NCT06621524
DVAL-PLAN-0062
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 routineclinical care are entered into the registry.

Exclusion

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 inwhich a routine angiographic follow-up is planned

  • A life expectancy of <1year

  • Explicit refusal of participation in the registry

Study Design

Total Participants: 251
Treatment Group(s): 1
Primary Treatment: EucaLimus coronary stent system
Phase:
Study Start date:
March 14, 2025
Estimated Completion Date:
October 31, 2028

Study 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.

Connect with a study center

  • Krajska nemocnice Liberec

    Liberec, 46001
    Czech Republic

    Active - Recruiting

  • Motol University Hospital

    Prague, 15006
    Czech Republic

    Active - Recruiting

  • Institut Jantung Negara

    Kuala Lumpur, 50400
    Malaysia

    Active - Recruiting

  • Bellvitge University Hospital

    L'Hospitalet de Llobregat, Catalonia 08907
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08026
    Spain

    Active - Recruiting

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