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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supraflex Cruz Sirolimus-eluting Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supraflex Cruz Sirolimus-eluting Stent | Device | Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device Oriented Composite Endpoint (DOCE) | DOCE is a composite of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically-driven target lesion revascularization (TLR) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All death, cardiovascular death and non-cardiovascular death | 6 months and 12 months | |
| All myocardial infarction (MI) | 6 months and 12 months | |
| Target vessel MI and MI not clearly attributable to non-target vessel |
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Inclusion Criteria:
Exclusion Criteria:
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All-comer patients affected by silent ischemia, stable angina or acute coronary syndrome (unstable angina and non-STEMI), who qualify for percutaneous coronary intervention (PCI), 400 patients of the population must qualify for HBR criteria
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Christoph K Naber, PD. Dr. Med. | Klinikum Wilhelmshaven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Haguenau | Haguenau | 67500 | France | |||
| Hôpital Privé Jacques Cartier |
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| 6 months and 12 months |
| Clinically indicated target lesion revascularization (TLR) | 6 months and 12 months |
| All target lesion revascularization (TLR) | Clinically and non-clinically indicated target lesion revascularization (TLR) | 6 months and 12 months |
| All target vessel revascularization (TVR) | Clinically and non-clinically indicated target vessel revascularization (TVR) | 6 months and 12 months |
| All revascularization | Any revascularization, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR | 6 months and 12 months |
| Stent thrombosis (ARC2) | 6 months and 12 months |
| Device success | Defined as deployment of the stents without system failure or device-related complication | Up to 1 Day |
| Lesion success | Defined as the attainment of < 50% residual stenosis of the target lesions post-PCI | Up to 1 Day |
| Procedure success | Defined as all lesion successfully treated without the occurrence of DOCE during the hospital stay | Up to 7 Days |
| Major bleeding (BARC 3 to 5) in the HBR population | 6 months and 12 months |
| Massy |
| 91300 |
| France |
| CHRU de Montpellier | Montpellier | 34295 | France |
| Hôpital Privé Claude Galien | Quincy-sous-Sénart | 91480 | France |
| Clinique Saint Hilaire | Rouen | 76000 | France |
| CHU de Toulouse - Rangueil | Toulouse | 31059 | France |
| Kerckhoff Heart Center | Bad Nauheim | 61231 | Germany |
| Heart and Diabetes Center Nordrhine Westfalia | Bad Oeynhausen | 32545 | Germany |
| Segeberg Kliniken | Bad Segeberg | 23795 | Germany |
| Charité Campus Mitte | Berlin | 10117 | Germany |
| Charité Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Charité Campus Virchow | Berlin | 13353 | Germany |
| St Johannes Hospital | Dortmund | 44137 | Germany |
| Herzzentrum Dresden - Universitätklinikum an der TU Dresden | Dresden | 01307 | Germany |
| Praxisklinik Dresden | Dresden | Germany |
| HELIOS Klinikum Erfurt | Erfurt | 99089 | Germany |
| University Hospital Erlangen | Erlangen | 35392 | Germany |
| Elizabeth Krankenhaus | Essen | 45138 | Germany |
| UKSH | Kiel | 24105 | Germany |
| Universität Leipzig - Herzzentrum | Leipzig | 04289 | Germany |
| Städtische Kliniken Neuss, Lukaskrankenhaus | Neuss | 41464 | Germany |
| Universitätsklinikum | Regensburg | 93053 | Germany |
| Klinikum Wilhelmshaven | Wilhelmshaven | 26389 | Germany |
| University and Hospital Fribourg | Fribourg | 1700 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | 9000 | Switzerland |
| University Hospital Zurich | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001161 | Arteriosclerosis |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001157 | Arterial Occlusive Diseases |
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