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| Name | Class |
|---|---|
| Eucatech AG | INDUSTRY |
| European Cardiovascular Research Center | NETWORK |
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To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Support C Drug Coated Balloon (DCB) in routine clinical practice.
This 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 Support C Drug Coated Balloon (DCB) according to the Instructions for Use as part of routine clinical care. Approximately 278 patients from 8-12 centers in Europe will be entered into the registry. Patients in 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, 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 |
|---|---|---|---|
| Drug Eluting SUPPORT C PTCA balloon catheter | The Drug Eluting SUPPORT C PTCA balloon catheter is indicated for use in patients with symptomatic ischaemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adjudicated, device-oriented, Target Lesion Failure (TLF) | Adjudicated, device-oriented, Target Lesion Failure (TLF) where TLF is defined 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) (by PCI or coronary artery bypass grafting). | 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, 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), and clinically driven target lesion revascularization (cd-TLR) ) |
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Inclusion Criteria:
Note:
Exclusion Criteria:
Patients are excluded if ANY of the following additional conditions apply:
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Patients with symptomatic ischemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses can be included in the study. The vessel diameter must be 2.0 - 4.0 mm.
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Alfonso, MD, PhD | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | 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 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| 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) a composite of all 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 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 |
| Adjudicated lesion thrombosis | through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months |
| Device success | Successful reaching of the target lesion, successful inflation and deflation of the balloon catheter, and a final residual stenosis after DCB treatment of ≤30% by visual assessment in the presence of grade 3 TIMI (Thrombolysis in Myocardial Infarction) flow, by visual estimation. | Index Procedure |
| Procedure success | Procedure success: Successful balloon delivery, deployment and retrieval and no peri-procedural death, TV-MI or TVR. | Index Procedure |
| Prague |
| 15006 |
| Czechia |
| Katholischen Krankenhaus "St. Johann Nepomuk" | Erfurt | 99097 | Germany |
| Evangelisches Krankenhaus Hagen-Haspe gGmbH | Hagen | 58135 | Germany |
| MediClin Herzzentrum Lahr | Lahr | 77933 | Germany |
| Martha Maria Nürnberg | Nuremberg | 90491 | Germany |
| National Heart Institute (Institut Jantung Negara) | Kuala Lumpur | 50400 | Malaysia |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08026 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | 27003 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Virgen de la Arrixaca | Murcia | 30120 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |