An observational study in Coronary Arterioscleroses, sponsored by OrbusNeich. Active, not recruiting at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by OrbusNeich · Observational
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 251 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →OrbusNeich is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients are excluded from registration if ANY of the following conditions apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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).
Time frame: 12 months post procedure
Adjudicated Target Lesion Failure (TLF)
Time frame: 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))
Time frame: 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)
Time frame: 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))
Time frame: 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
Time frame: 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
Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated stroke
Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Device success
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
Time frame: Index Procedure
Procedure Success
Procedure Success: Device success and no peri-procedural death, MI or TVR.
Time frame: Index Procedure
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Jan 2027, 22 months after the start.
Of 125 industry-sponsored observational studies under Coronary Artery Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's planned 22 months is below that.
Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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