Coronary Angioplasty With Sirolimus Drug-coated Stent System to Treat Patients With Symptomatic Ischemic Coronary Heart Disease: a PMCF Study.
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- OrbusNeich
- Enrollment
- 251
- Locations
- 10
- Primary Endpoint
- Adjudicated, device-oriented, Target Lesion Failure (TLF)
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: EucaLimus coronary stent system (Device)
Outcomes
Primary Outcomes
Adjudicated, device-oriented, Target Lesion Failure (TLF)
Time Frame: 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 Outcomes
- 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)
- Procedure Success(Index Procedure)