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

Coronary Heart Disease Clinical Trial

— PE-Prove  

Official title:

PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148329
• Other study ID #: S2057
• Status: Completed
• Phase: N/A
• First received: June 21, 2010
• Last updated: February 1, 2017
• Start date: June 2010
• Est. completion date: December 2016

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1010
• Est. completion date: December 2016
• Est. primary completion date: June 2012
• 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

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.

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus der Stadt Linz	Linz
Austria	Medizinische Universität Wien	Vienna
Austria	Klinikum Wels-Grieskirchen	Wels
Belgium	Virga Jesse Ziekenhuis	Hasselt
Belgium	Centre Hôpital Universitaire Sart Tilman	Liege
Denmark	Odense University Hospital	Odense
Denmark	Roskilde Sygehus	Roskilde
France	Centre Hospitalier Privé Saint Martin gds	Caen
France	Le Centre Chirurgical Marie Lannelongue	Le Plessis Robinson
France	Polyclinique les Fleurs	Ollioules
France	Clinique St. Martin	Pessac
France	Clinique Saint-Hilaire Rouen	Rouen
France	Clinique Pasteur	Toulouse
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH	Bad Segeberg
Germany	Universitätsklinikum Bonn	Bonn	NRW
Germany	Klinikum Darmstadt	Darmstadt
Germany	Universitätsklinikum Düsseldorf	Düsseldorf	NRW
Germany	Med. Hochschule Hannover	Hannover
Germany	Klinikum Leverkusen	Leverkusen	NRW
Germany	Schwarzwald Baar Klinikum Villingen-Schwenningen	Villingen-Schwenningen
Hungary	Dept. of Internal Medicine and Cardiological Center	Szeged
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St. James's Hospital	Dublin
Ireland	Galway University Hospital	Galway
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Centro Cardiologico Monzino	Milano
Italy	Clinica Mediterranea	Napoli
Italy	IRCCS Policlinico S. Matteo	Pavia
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Canisius Wilhelmina Ziekenhuis	Nijmegen
Spain	Hospital Universitari Germans Trias i Pujol	Barcelona
Spain	Hospital Universitario La Paz	Madrid
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	King's College Hospital London	London
United Kingdom	St. Thomas Hospital	London
United Kingdom	Freeman, Newcastle-Upon-Tyne	Newcastle-Upon-Tyne

Sponsors (3)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Medidata Solutions, Pharmaceutical Research Associates

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Hungary,  Ireland,  Italy,  Netherlands,  Spain,  United Kingdom, 

References & Publications (1)

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 multi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Death or MI rates	Overall and PROMUS™ Element™ stent-related cardiac death or MI rates	30 days, 6 months, 12 months and then annually through 5 years
Secondary	TVR rates	Overall and PROMUS™ Element™ stent-related TVR rates.	30 days, 6 months, 12 months and then annually through 5 years
Secondary	Cardiac death rates	Overall and PROMUS™ Element™ stent-related cardiac death rates.	30 days, 6 months, 12 months and then annually through 5 years
Secondary	MI Rates	Overall and PROMUS™ Element™ stent-related MI rates.	30 days, 6 months, 12 months and then annually through 5 years
Secondary	All death rates	All death rates	30 days, 6 months, 12 months and then annually through 5 years
Secondary	Non-cardiac death rates	Non-cardiac death rates	30 days, 6 months, 12 months and then annually through 5 years
Secondary	All death or MI rates	All death and MI rates	30 days, 6 months, 12 months and then annually through 5 years