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

Coronary Heart Disease Clinical Trial

— TE-Prove  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242696
• Other study ID #: S2059
• Status: Completed
• Phase: N/A
• First received: November 16, 2010
• Last updated: February 2, 2017
• Start date: November 2010
• Est. completion date: July 2015

Study information

• Verified date: February 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1014
• Est. completion date: July 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• According to Instructions For Use

Exclusion Criteria:

• Contraindications according to Instructions for Use

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Procedure:
• Coronary artery stenting
Coronary artery stenting with drug eluting stents

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Sint-Jan	Brugge
Belgium	CHU de Charleroi - ISPPC	Charleroi
Belgium	H-Hartziekenhuis Roeselare-Menen vzw	Roeselare
France	CH Avignon	Avignon
France	CHU Besancon	Besancon
France	Centre Hospitalier Privé Saint Martin gds	Caen
France	CHU Grenoble	Grenoble
France	Hôpital Privé Clairval	Marseille
France	CHG de Pau	Pau
France	Clinique Saint-Hilaire Rouen	Rouen
France	Centre Hôpital Universitaire Rangueuil	Toulouse
Germany	Klinikum Coburg gGmbH	Coburg
Germany	Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR	Dresden
Germany	Augusta Krankenhaus	Dusseldorf
Germany	Kardiocentrum Frankfurt	Frankfurt	Hessen
Germany	Krankenhaus Landshut-Achdorf	Landshut
Germany	Krankenhaus d. Barmherzigen Brüder	Trier	Rheinland Pfalz
Hungary	Medical School of University PECS	Pecs
Ireland	Galway University Hospital	Galway
Italy	Ospedale Cannizzaro	Catania
Italy	Ospedale Ferrarotto	Catania
Italy	Ospedale Misericordia ASL 9	Grosseto
Italy	Azienda Ospedaliera Papardo	Messina
Latvia	P. Stradins University Hospital	Riga
Poland	Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II	Grodzisk Mazowiecki
Spain	Hospital General de Albacete	Albacete
Spain	Hospital Universitario de Bellvitge	Barcelona
Spain	Hospital General De Leon	León
Spain	Hospital La Paz	Madrid
Spain	H. Marques De Valdecilla	Santander
United Kingdom	Royal Bournemouth General Hospital	Bournemouth
United Kingdom	Craigavon Hospital, Southern Trust	Craigavon	Northern Ireland
United Kingdom	Lister	Hertfordshire
United Kingdom	London Chest Hospital	London
United Kingdom	Freeman Hospital	Newcastle upon -Tyne
United Kingdom	Norfolk and Norwich University Hospital NHS Trust	Norwich
United Kingdom	New Cross Hospital	Wolverhampton

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Pharmaceutical Research Associates

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hungary,  Ireland,  Italy,  Latvia,  Poland,  Spain,  United Kingdom, 

References & Publications (1)

Tamburino C, Capodanno D, Erglis A, Menown IB, Horváth 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 endpo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	MACE	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	All Death	All Death rates	30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Secondary	Non-Cardiac Death	Non-Cardiac Death rates	30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Secondary	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