EucaLimus Post-Market Registry

Not yet recruiting

• Conditions: Coronary Arterioscleroses
• Interventions: Device: EucaLimus coronary stent system

• Registration Number: NCT06621524
• Lead Sponsor: OrbusNeich

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study Start: 2024-10
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Primary Completion: 2026-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 251

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device: EucaLimus coronary stent system	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.

Primary Outcome Measures

Name	Time	Method
Adjudicated, device-oriented, Target Lesion Failure (TLF)	12 months post procedure	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).

Secondary Outcome Measures

Name	Time	Method
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
Adjudicated bleeding Type 3-5 per the Bleeding Academic Research Consortium (BARC) definition	through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated stroke	through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Device success	Index Procedure	Device success: Percentage of patients with a successful delivery and deployment of the EucaLimus stent at the target lesion and final diameter stenosis after stenting ≤20% by visual assessment in the presence of grade 3 TIMI (Thrombolysis in Myocardial Infarction) flow, by visual estimation EucaLimus stent at the target lesion and a final diameter stenosis after stenting ≤20% by visual assessment in the presence of grade 3 TIMI flow, by visual estimation
Procedure Success	Index Procedure	Procedure Success: Device success and no peri-procedural death, MI or TVR.