PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study (PE-Prove)

February 1, 2017 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1010

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, A-4020
        • Allgemeines Krankenhaus der Stadt Linz
      • Vienna, Austria, A-1090
        • Medizinische Universität Wien
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen
  • Belgium
      • Hasselt, Belgium, 3500
        • Virga Jesse Ziekenhuis
      • Liege, Belgium, B4000
        • Centre Hôpital Universitaire Sart Tilman
  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Roskilde, Denmark, 4000
        • Roskilde Sygehus
  • France
      • Caen, France, 14000
        • Centre Hospitalier Privé Saint Martin gds
      • Le Plessis Robinson, France, 92350
        • Le Centre Chirurgical Marie Lannelongue
      • Ollioules, France, 83192
        • Polyclinique les Fleurs
      • Pessac, France, 33608
        • Clinique St. Martin
      • Rouen, France, 76000
        • Clinique Saint-Hilaire Rouen
      • Toulouse, France, 31076
        • Clinique Pasteur
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Bad Segeberg, Germany, 23795
        • Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt
      • Hannover, Germany, 30625
        • Med. Hochschule Hannover
      • Villingen-Schwenningen, Germany, 78050
        • Schwarzwald Baar Klinikum Villingen-Schwenningen
    • NRW
      • Bonn, NRW, Germany, 53105
        • Universitätsklinikum Bonn
      • Düsseldorf, NRW, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • Leverkusen, NRW, Germany, 51375
        • Klinikum Leverkusen
  • Hungary
      • Szeged, Hungary, 6720
        • Dept. of Internal Medicine and Cardiological Center
  • Ireland
      • Dublin, Ireland
        • Mater Misericordiae University Hospital
      • Dublin, Ireland
        • St. James's Hospital
      • Dublin, Ireland, D9
        • Beaumont Hospital
      • Galway, Ireland
        • Galway University Hospital
  • Italy
      • Bergamo, Italy, 24128
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Milano, Italy, 20138
        • Centro Cardiologico Monzino
      • Napoli, Italy, 80121
        • Clinica Mediterranea
      • Pavia, Italy, 27100
        • IRCCS Policlinico S. Matteo
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5211 RW
        • Jeroen Bosch Ziekenhuis
      • Dordrecht, Netherlands, 3300 AK
        • Albert Schweitzer Ziekenhuis
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius Wilhelmina Ziekenhuis
  • Spain
      • Barcelona, Spain, 8916
        • Hospital Universitari Germans Trias I Pujol
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
  • United Kingdom
      • Cambridge, United Kingdom, CB23 3RE
        • Papworth Hospital
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • London, United Kingdom, SE1 7EH
        • St. Thomas Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital London
      • Newcastle-Upon-Tyne, United Kingdom, NE7 7DN
        • Freeman, Newcastle-Upon-Tyne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • According to Instructions For Use

Exclusion Criteria:

  • Contraindications according to Instructions for Use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Vessel Failure (TVF)
Time Frame: One year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR)
Time Frame: 30 days, 6 months, 12 months and then annually through 5 years
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
Time Frame: 30 days, 6 months, 12 months and then annually through 5 years
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
Time Frame: 30 days, 6 months, 12 months and then annually through 5 years
Overall and PROMUS™ Element™ stent-related TVR rates.
30 days, 6 months, 12 months and then annually through 5 years
Cardiac death rates
Time Frame: 30 days, 6 months, 12 months and then annually through 5 years
Overall and PROMUS™ Element™ stent-related cardiac death rates.
30 days, 6 months, 12 months and then annually through 5 years
MI Rates
Time Frame: 30 days, 6 months, 12 months and then annually through 5 years
Overall and PROMUS™ Element™ stent-related MI rates.
30 days, 6 months, 12 months and then annually through 5 years
All death rates
Time Frame: 30 days, 6 months, 12 months and then annually through 5 years
All death rates
30 days, 6 months, 12 months and then annually through 5 years
Non-cardiac death rates
Time Frame: 30 days, 6 months, 12 months and then annually through 5 years
Non-cardiac death rates
30 days, 6 months, 12 months and then annually through 5 years
All death or MI rates
Time Frame: 30 days, 6 months, 12 months and then annually through 5 years
All death and MI rates
30 days, 6 months, 12 months and then annually through 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

Pharmaceutical Research Associates
Medidata Solutions

Investigators

  • Study Director: Peter Maurer, PhD, Boston Scientific Corporation
  • Principal Investigator: Raul Moreno, MD PhD, Hospital La Paz, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are presented at the 2013 EuroPCR congress.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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