Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice (ENERGY)

January 29, 2016 updated by: Biotronik AG

Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice Multinational, Prospective, Non-randomized, Multi-centre, Non-interventional Trial

To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.

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.
1026

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
      • Bruck an der Mur, Austria
        • Landeskrankenhaus Bruck an der Mur
      • Schwarzach st. Veit, Austria
        • Kardinal Schwarzenberg'sches Krankenhaus
  • Belgium
      • Brussels, Belgium
        • Saint-Pierre University Hospital
      • Yvoir, Belgium
        • Cliniques Universitaires UCL de Mont-Godinne
  • France
      • Aix en Provence, France
        • Clinique Axium
      • Avignon, France
        • Clinique Rhône Durance
      • Bourg en Bresse, France
        • Clinique Convert
      • Chartres, France
        • Centre Hospitalier de Chartres
      • Grenoble, France
        • Clinique la Mutualiste
      • Marignane, France
        • Clinique Générale de Marignane
      • Pau, France
        • Centre Hospitalier de Pau
      • Perpignan, France
        • Clinique Saint Pierre
  • Germany
      • Bad Oeynhausen, Germany
        • Herz- und Diabeteszentrum Nordrhein-Westfalen
      • Berlin, Germany
        • Charité-Universitätsm. Berlin Campus Charité-Mitte
      • Berlin, Germany
        • Vivantes Humboldt Klinikum
      • Bonn, Germany
        • Universitatsklinikum Bonn
      • Dortmund, Germany
        • Klinikum Dortmund GmbH
      • Dresden, Germany
        • Städ. Klinikum Dresden- Friedrichstadt
      • Essen, Germany
        • Alfried Krupp Klinikum Essen
      • Essen, Germany
        • Vinzenz Krankenhaus
      • Hamburg, Germany
        • Asklepios Klinikum St. Georg
      • Lünen, Germany
        • St. Marien Hospital
      • Osnabrück, Germany
        • Niels-Stensen-Kliniken Marienhospital Osnabrück
      • Regensburg, Germany
        • Universitätsklinikum Regensburg
      • Speyer, Germany
        • Diakonissen-Stiftungs-Krankenhaus Speyer
      • Stade, Germany
        • Elbe Klinikum Stade GmbH
      • Suhl, Germany
        • SRH Zentralklinikum Suhl
      • Witten, Germany
        • Marien-Hospital Witten GmbH
    • NRW
      • Essen, NRW, Germany, 45122
        • Westdeutsches Herzzentrum Essen
  • Ireland
      • Craigavon, Ireland
        • Craigavon Cardiac Centre
  • Israel
      • Beer Yakov, Israel
        • Assaf Harofeh Medical Center
      • Haifa, Israel
        • Rambam Medical Center
      • Haifa, Israel
        • Carmel Medical Center
      • Rehovot, Israel
        • Kaplan Medical Center
      • Zefat, Israel
        • Ziv Medical Center
  • Latvia
      • Riga, Latvia
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia
        • Riga East Clinical University Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • VU Medisch Centrum
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis
      • Maastricht, Netherlands
        • Academisch Ziekenhuis Maastricht
  • Spain
      • Almeria, Spain
        • Hospital Torrecardenas
      • Barcelona, Spain
        • Hospital Clinic i Provinvial de Barcelona
      • Barcelona, Spain
        • Hospital de la santa Creu i San Pau
      • Caceres, Spain
        • Hospital San Pedro De Alcantara
      • Madrid, Spain
        • Hospital de Puerta de Hierro
      • Vigo, Spain
        • Hospital Mexoeiro
      • Vizcaya, Spain
        • Hospital Galdakao
  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
      • Lausanne, Switzerland
        • Clinique Cecil
      • Zürich, Switzerland
        • University Hospital Zurich

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

Inclusion Criteria:

  • Patient signed informed consent for data release
  • Patient eligible for percutaneous coronary intervention (PCI)
  • De novo and re-stenosed coronary artery lesions
  • Patient is geographically stable and willing to participate at all follow up assessments
  • Patient is > 18 years of age

Exclusion Criteria:

  • Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel
  • Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI
  • Patient presents with ISR (in-stent restenosis)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
ENERGY-Population

Patient population in standard clinical care, according to the instructions for use and the inclusion / exclusion criteria. Registry patients should be enrolled consecutively to represent a typical set of patients at each site.

The registry will collect clinical data from patients that have given their prior written consent. All data will be anonymized prior to data entry.
Device: Pro Kinetic Energy bare metal stent
PCI

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
Time Frame
MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI)
Time Frame: 6 months
6 months

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
Time Frame
• MACE after 12 and 24 months • TVR after 6, 12 and 24 months • Stent Thrombosis at 6, 12 and 24 months acc. to the academic research consortium -ARC (13)
Time Frame: 6,12, 24 Months
6,12, 24 Months

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.
Biotronik AG

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.
  • Principal Investigator: Raimund Erbel, MD, Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany

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.
March 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.
February 1, 2013

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, 2013

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).
January 25, 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.
January 25, 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.
January 26, 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 1, 2016

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.
January 29, 2016

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.
January 1, 2016

More Information

Terms related to this study

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.
  • C0903

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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