PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study

CompletedOBSERVATIONAL
Enrollment

1,010

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

June 30, 2012

Study Completion Date

December 31, 2016

Conditions
Coronary Heart Disease
Interventions
DEVICE

Coronary stenting

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.

Trial Locations (40)

3500

Virga Jesse Ziekenhuis, Hasselt

4000

Roskilde Sygehus, Roskilde

4600

Klinikum Wels-Grieskirchen, Wels

5000

Odense University Hospital, Odense

6720

Dept. of Internal Medicine and Cardiological Center, Szeged

8916

Hospital Universitari Germans Trias i Pujol, Barcelona

14000

Centre Hospitalier Privé Saint Martin gds, Caen

20138

Centro Cardiologico Monzino, Milan

23795

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH, Bad Segeberg

24128

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

27100

IRCCS Policlinico S. Matteo, Pavia

28046

Hospital Universitario La Paz, Madrid

30625

Med. Hochschule Hannover, Hanover

31076

Clinique Pasteur, Toulouse

33608

Clinique St. Martin, Pessac

40225

Universitätsklinikum Düsseldorf, Düsseldorf

51375

Klinikum Leverkusen, Leverkusen

53105

Universitätsklinikum Bonn, Bonn

64283

Klinikum Darmstadt, Darmstadt

76000

Clinique Saint-Hilaire Rouen, Rouen

78050

Schwarzwald Baar Klinikum Villingen-Schwenningen, Villingen-Schwenningen

80121

Clinica Mediterranea, Napoli

83192

Polyclinique les Fleurs, Ollioules

92350

Le Centre Chirurgical Marie Lannelongue, Le Plessis-Robinson

99437

Zentralklinik Bad Berka GmbH, Bad Berka

A-4020

Allgemeines Krankenhaus der Stadt Linz, Linz

A-1090

Medizinische Universität Wien, Vienna

B4000

Centre Hôpital Universitaire Sart Tilman, Liège

D9

Beaumont Hospital, Dublin

Unknown

Mater Misericordiae University Hospital, Dublin

St. James's Hospital, Dublin

Galway University Hospital, Galway

5211 RW

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch

3300 AK

Albert Schweitzer Ziekenhuis, Dordrecht

6532 SZ

Canisius Wilhelmina Ziekenhuis, Nijmegen

CB23 3RE

Papworth Hospital, Cambridge

CF14 4XW

University Hospital of Wales, Cardiff

SE1 7EH

St. Thomas Hospital, London

SE5 9RS

King's College Hospital London, London

NE7 7DN

Freeman, Newcastle-Upon-Tyne, Newcastle upon Tyne

All Listed Sponsors
collaborator

Pharmaceutical Research Associates

OTHER

collaborator

Medidata Solutions

INDUSTRY

lead

Boston Scientific Corporation

INDUSTRY