TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study (TE-Prove)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pharmaceutical Research Associates, Inc.
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01242696
First received: November 16, 2010
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Procedure: Coronary artery stenting

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the TAXUS® Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Target Vessel failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Stent Thrombosis [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Stent Thrombosis (ST) rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Reintervention, (TLR)).

  • MACE [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Overall and TAXUS Element stent-related Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR).

  • Cardiac Death or MI [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Overall and TAXUS Element stent-related cardiac death or MI rates

  • TVR [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Overall and TAXUS Element stent-related TVR rates

  • Cardiac Death [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Overall and TAXUS Element stent-related cardiac death rates

  • MI [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Overall and TAXUS Element stent-related MI rates

  • All Death [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    All Death rates

  • Non-Cardiac Death [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Non-Cardiac Death rates

  • All Death or MI [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    All Death or MI rates


Enrollment: 1014
Study Start Date: November 2010
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: Coronary artery stenting
Coronary artery stenting with drug eluting stents
Other Name: TAXUS Element

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • According to Instructions For Use

Exclusion Criteria:

  • Contraindications according to Instructions for Use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242696

  Hide Study Locations
Locations
Belgium
St. Jan Brugge
Brugge, Belgium, 8000
CHU de Charleroi - ISPPC
Charleroi, Belgium, 6000
H-Hartziekenhuis Roeselare-Menen vzw
Roeselare, Belgium, 8800
France
Centre Médico - Chirugical Claude Bernard Albi
Albi, France
CH Avignon - see ssq
Avignon, France, 84902
CHU Besancon
Besancon, France, 25030
CHP St. Martin
Caen, France, 14000
CHU Grenoble - CHU Michallon
Grenoble, France, 38043
Clinique Bouchard
Marseille, France, 13006
CHG de Pau
Pau, France, 64046
Clinique Saint-Hilaire Rouen
Rouen, France, 7600
Centre Cardiologique du Nord
Saint-Denis, France
Centre Hôpital Universitaire Rangueuil
Toulouse, France, 31059
Germany
Kardiocentrum Frankfurt, Klinik Rotes Kreuz
Frankfurt, Hessen, Germany, 60316
Krankenhaus d. Barmherzigen Brüder
Trier, Rheinland Pfalz, Germany, 76133
Klinikum Coburg GmbH
Coburg, Germany, 96450
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
Dresden, Germany, 1324
Augusta Krankenhaus VKKD
Dusseldorf, Germany, 40472
Krankenhaus Landshut-Achdorf
Landshut, Germany, 84036
Hungary
Hungarian Institute of Cardiology
Budapest, Hungary, 1096
Medical School of University PECS
Pecs, Hungary, 7632
Ireland
Galway University Hospital
Galway, Ireland
Italy
Asp Agrigento
Agrigento, Italy, 92100
Ospedale Ferrarotto
Catania, Italy, 95100
Ospedale Cannizzaro
Catania, Italy, 95126
Ospedale Misericordia ASL 9
Grosseto, Italy, 58100
Azienda Ospedaliera Papardo
Messina, Italy, 98161
Azienda Ospedaliera di Padova
Padova, Italy, 35100
Latvia
P. Stradins University Hospital
Riga, Latvia, LV-1002
Poland
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
Grodzisk Mazowiecki, Poland, 05-825
Spain
Complejo Hospitalario Universitario de Albacete
Albacete, Spain, 2006
Bellvitge Hospital
Barcelona, Spain, 8907
Hospital General De Leon
León, Spain, 24008
Hospital La Paz
Madrid, Spain, 28046
H. Marques De Valdecilla
Santander, Spain, 39008
United Kingdom
Craigavon Hospital, Southern Trust
Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Lister
Hertfordshire, United Kingdom
London Chest Hospital
London, United Kingdom, E2 9JX
Freeman Hospital
Newcastle upon -Tyne, United Kingdom, NE7 7DN
Norfolk and Norwich University Hospital NHS Trust
Norwich, United Kingdom, NR4 &UY
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Boston Scientific Corporation
Pharmaceutical Research Associates, Inc.
Investigators
Principal Investigator: Corrado Tamburino, Prof. Ospedale Ferrarotto, Via Citelli, 1, 95100 Catania, Italy
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01242696     History of Changes
Other Study ID Numbers: S2059
Study First Received: November 16, 2010
Last Updated: December 19, 2013
Health Authority: Belgium: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
Italy: Ethics Committee
Poland: Ethics Committee
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Boston Scientific Corporation:
Drug Eluting Stents
Observational
All-Comers

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014