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| Name | Class |
|---|---|
| Pharmaceutical Research Associates | OTHER |
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The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.
A prospective, open label, multi-center observational study with an all-comers enrollment approach of approximately 1000 subjects at up to 50 sites in Europe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary artery stenting | All subjects who are candidates for coronary artery stenting, signed the Informed Consent Form and are eligible to receive a TAXUS Element stent will be evaluated for enrollment in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary artery stenting | Procedure | Coronary artery stenting with drug eluting stents |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel failure | Overall and TAXUS Element stent related Target Vessel Failure (TVF) rate (cardiac death, myocardial infarction (MI) related to target vessel and target vessel re-intervention (TVR)) at 12 months post stent implantation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Thrombosis | Stent Thrombosis (ST) rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Reintervention, (TLR)). | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation |
| MACE |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects who are candidates for coronary artery stenting, signed the Informed Consent Form and are eligible to receive a TAXUS Element stent will be evaluated for enrollment in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Corrado Tamburino, Prof. | Ospedale Ferrarotto, Via Citelli, 1, 95100 Catania, Italy | Principal Investigator |
| Peter Maurer, PhD | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Ziekenhuis Sint-Jan | Bruges | 8000 | Belgium | |||
| CHU de Charleroi - ISPPC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25572023 | Result | Tamburino C, Capodanno D, Erglis A, Menown IB, Horvath IG, Moreno R, Gilbert TJ, Crowley JJ, Calabria P, Allocco DJ, Dawkins KD. One-year outcomes in unselected patients treated with a thin-strut, platinum-chromium, paclitaxel-eluting stent: primary endpoint results from the TAXUS Element European post-approval surveillance study (TE-PROVE). EuroIntervention. 2015 Mar;10(11):1261-6. doi: 10.4244/EIJY15M01_01. |
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Primary endpoint data presented at TCT 2014.
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Overall and TAXUS Element stent-related Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR). |
| 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation |
| Cardiac Death or MI | Overall and TAXUS Element stent-related cardiac death or MI rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation |
| TVR | Overall and TAXUS Element stent-related TVR rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation |
| Cardiac Death | Overall and TAXUS Element stent-related cardiac death rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation |
| MI | Overall and TAXUS Element stent-related MI rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation |
| All Death | All Death rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation |
| Non-Cardiac Death | Non-Cardiac Death rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation |
| All Death or MI | All Death or MI rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation |
| Charleroi |
| 6000 |
| Belgium |
| H-Hartziekenhuis Roeselare-Menen vzw | Roeselare | 8800 | Belgium |
| CH Avignon | Avignon | 84902 | France |
| CHU Besancon | Besançon | 25030 | France |
| Centre Hospitalier Privé Saint Martin gds | Caen | 14000 | France |
| CHU Grenoble | Grenoble | 38043 | France |
| Hôpital Privé Clairval | Marseille | 13006 | France |
| CHG de Pau | Pau | 64046 | France |
| Clinique Saint-Hilaire Rouen | Rouen | 7600 | France |
| Centre Hôpital Universitaire Rangueuil | Toulouse | 31059 | France |
| Kardiocentrum Frankfurt | Frankfurt am Main | Hesse | 60316 | Germany |
| Krankenhaus d. Barmherzigen Brüder | Trier | Rhineland-Palatinate | 76133 | Germany |
| Klinikum Coburg gGmbH | Coburg | 96450 | Germany |
| Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR | Dresden | 1324 | Germany |
| Augusta Krankenhaus | Düsseldorf | 40472 | Germany |
| Krankenhaus Landshut-Achdorf | Landshut | 84036 | Germany |
| Medical School of University PECS | Pécs | 7632 | Hungary |
| Galway University Hospital | Galway | Ireland |
| Ospedale Ferrarotto | Catania | 95100 | Italy |
| Ospedale Cannizzaro | Catania | 95126 | Italy |
| Ospedale Misericordia ASL 9 | Grosseto | 58100 | Italy |
| Azienda Ospedaliera Papardo | Messina | 98161 | Italy |
| P. Stradins University Hospital | Riga | LV-1002 | Latvia |
| Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II | Grodzisk Mazowiecki | 05-825 | Poland |
| Hospital General de Albacete | Albacete | 2006 | Spain |
| Hospital Universitario de Bellvitge | Barcelona | 8907 | Spain |
| Hospital General De Leon | León | 24008 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| H. Marques De Valdecilla | Santander | 39008 | Spain |
| Craigavon Hospital, Southern Trust | Craigavon | Northern Ireland | BT63 5QQ | United Kingdom |
| Royal Bournemouth General Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Lister | Hertfordshire | United Kingdom |
| London Chest Hospital | London | E2 9JX | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Norfolk and Norwich University Hospital NHS Trust | Norwich | NR4 &UY | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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