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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Universitatsklinikum 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pharmaceutical Research Associates
Medidata Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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