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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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 Zürich

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

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
Intervention / Treatment
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

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

Secondary Outcome Measures

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

Biotronik AG

Investigators

  • 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

March 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID 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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