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| Name | Class |
|---|---|
| Pharmaceutical Research Associates | OTHER |
| Medidata Solutions | INDUSTRY |
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The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm observational study | To evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary stenting | Device | The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm. |
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure (TVF) | Overall and PROMUS™ Element™ stent related TVF rate (cardiac death, myocardial infarction (MI) related to target vessel and target vessel re-intervention (TVR)) at 12 months post stent implantation. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR) | Overall and PROMUS™ Element™ stent-related MACE rates (cardiac death, MI, TVR). | 30 days, 6 months, 12 months and then annually through 5 years |
| Death or MI rates |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who are candidates for Coronary artery stenting, signed the Informed Consent Form and are eligible to receive a PROMUS™ Element™ stent will be evaluated for enrollment in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Raul Moreno, MD PhD | Hospital La Paz, Spain | Principal Investigator |
| Peter Maurer, PhD | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus der Stadt Linz | Linz | A-4020 | Austria | |||
| Medizinische Universität Wien |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25631367 | Result | Thomas MR, Birkemeyer R, Schwimmbeck P, Legrand V, Moreno R, Briguori C, Werner N, Bramucci E, Ungi I, Richardt G, Underwood PL, Dawkins KD. One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study. EuroIntervention. 2015 Mar;10(11):1267-71. doi: 10.4244/EIJY15M01_07. |
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Data are presented at the 2013 EuroPCR congress.
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|
Overall and PROMUS™ Element™ stent-related cardiac death or MI rates
| 30 days, 6 months, 12 months and then annually through 5 years |
| TVR rates | Overall and PROMUS™ Element™ stent-related TVR rates. | 30 days, 6 months, 12 months and then annually through 5 years |
| Cardiac death rates | Overall and PROMUS™ Element™ stent-related cardiac death rates. | 30 days, 6 months, 12 months and then annually through 5 years |
| MI Rates | Overall and PROMUS™ Element™ stent-related MI rates. | 30 days, 6 months, 12 months and then annually through 5 years |
| All death rates | All death rates | 30 days, 6 months, 12 months and then annually through 5 years |
| Non-cardiac death rates | Non-cardiac death rates | 30 days, 6 months, 12 months and then annually through 5 years |
| All death or MI rates | All death and MI rates | 30 days, 6 months, 12 months and then annually through 5 years |
| Vienna |
| A-1090 |
| Austria |
| Klinikum Wels-Grieskirchen | Wels | 4600 | Austria |
| Virga Jesse Ziekenhuis | Hasselt | 3500 | Belgium |
| Centre Hôpital Universitaire Sart Tilman | Liège | B4000 | Belgium |
| Odense University Hospital | Odense | 5000 | Denmark |
| Roskilde Sygehus | Roskilde | 4000 | Denmark |
| Centre Hospitalier Privé Saint Martin gds | Caen | 14000 | France |
| Le Centre Chirurgical Marie Lannelongue | Le Plessis-Robinson | 92350 | France |
| Polyclinique les Fleurs | Ollioules | 83192 | France |
| Clinique St. Martin | Pessac | 33608 | France |
| Clinique Saint-Hilaire Rouen | Rouen | 76000 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Universitätsklinikum Bonn | Bonn | North Rhine-Westphalia | 53105 | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Klinikum Leverkusen | Leverkusen | North Rhine-Westphalia | 51375 | Germany |
| Zentralklinik Bad Berka GmbH | Bad Berka | 99437 | Germany |
| Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH | Bad Segeberg | 23795 | Germany |
| Klinikum Darmstadt | Darmstadt | 64283 | Germany |
| Med. Hochschule Hannover | Hanover | 30625 | Germany |
| Schwarzwald Baar Klinikum Villingen-Schwenningen | Villingen-Schwenningen | 78050 | Germany |
| Dept. of Internal Medicine and Cardiological Center | Szeged | 6720 | Hungary |
| Beaumont Hospital | Dublin | D9 | Ireland |
| Mater Misericordiae University Hospital | Dublin | Ireland |
| St. James's Hospital | Dublin | Ireland |
| Galway University Hospital | Galway | Ireland |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24128 | Italy |
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Clinica Mediterranea | Naples | 80121 | Italy |
| IRCCS Policlinico S. Matteo | Pavia | 27100 | Italy |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5211 RW | Netherlands |
| Albert Schweitzer Ziekenhuis | Dordrecht | 3300 AK | Netherlands |
| Canisius Wilhelmina Ziekenhuis | Nijmegen | 6532 SZ | Netherlands |
| Hospital Universitari Germans Trias i Pujol | Barcelona | 8916 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Papworth Hospital | Cambridge | CB23 3RE | United Kingdom |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| St. Thomas Hospital | London | SE1 7EH | United Kingdom |
| King's College Hospital London | London | SE5 9RS | United Kingdom |
| Freeman, Newcastle-Upon-Tyne | Newcastle upon Tyne | NE7 7DN | 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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