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| Name | Class |
|---|---|
| Eucatech AG | INDUSTRY |
| Centre Européen de Recherche Cardiovasculaire | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)) |
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Inclusion Criteria:
Exclusion Criteria:
Patients are excluded from registration if ANY of the following conditions apply:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Josep Gomez-Lara, MD, PhD | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krajska nemocnice Liberec | Liberec | 46001 | Czechia | |||
| Motol University Hospital |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| 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 | 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 | Index Procedure |
| Procedure Success | Procedure Success: Device success and no peri-procedural death, MI or TVR. | Index Procedure |
| Prague |
| 15006 |
| Czechia |
| Institut Jantung Negara | Kuala Lumpur | 50400 | Malaysia |
| Bellvitge University Hospital | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08026 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | 27003 | Spain |
| Complejo Hospitalario Universitario de Canarias | San Cristóbal de La Laguna | 38320 | Spain |
| Hospital Universitario Joan XXIII | Tarragona | 43005 | Spain |