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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01056120
First received: January 25, 2010
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
De Novo and Re-stenosed Coronary Artery Lesions
Device: Pro Kinetic Energy bare metal stent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1026
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056120

  Hide Study Locations
Locations
Austria
Landeskrankenhaus Bruck an der Mur
Bruck an der Mur, Austria
Kardinal Schwarzenberg'sches Krankenhaus
Schwarzach st. Veit, Austria
Belgium
Saint-Pierre University Hospital
Brussels, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Belgium
France
Clinique Axium
Aix en Provence, France
Clinique Rhone Durance
Avignon, France
Clinique Convert
Bourg en Bresse, France
Centre Hospitalier de Chartres
Chartres, France
Clinique la Mutualiste
Grenoble, France
Clinique Générale de Marignane
Marignane, France
Centre Hospitalier de Pau
Pau, France
Clinique Saint Pierre
Perpignan, France
Germany
Westdeutsches Herzzentrum Essen
Essen, NRW, Germany, 45122
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, Germany
Charité-Universitätsm. Berlin Campus Charité-Mitte
Berlin, Germany
Vivantes Humboldt Klinikum
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Klinikum Dortmund GmbH
Dortmund, Germany
Städ. Klinikum Dresden- Friedrichstadt
Dresden, Germany
Vinzenz Krankenhaus
Essen, Germany
Alfried Krupp Klinikum Essen
Essen, Germany
Asklepios Klinikum St. Georg
Hamburg, Germany
St. Marien Hospital
Lünen, Germany
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, Germany
Elbe Klinikum Stade GmbH
Stade, Germany
SRH Zentralklinikum Suhl
Suhl, Germany
Marien-Hospital Witten GmbH
Witten, Germany
Ireland
Craigavon Cardiac Centre
Craigavon, Ireland
Israel
Assaf Harofeh Medical Center
Beer Yakov, Israel
Rambam Medical Center
Haifa, Israel
Carmel Medical Center
Haifa, Israel
Kaplan Medical Center
Rehovot, Israel
Ziv Medical Center
Zefat, Israel
Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia
Riga East Clinical University Hospital
Riga, Latvia
Netherlands
VU Medisch Centrum
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Spain
Hospital Torrecardenas
Almeria, Spain
Hospital Clinic I Provinvial de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i San Pau
Barcelona, Spain
Hospital San Pedro de Alcantara
Caceres, Spain
Hospital de Puerta de Hierro
Madrid, Spain
Hospital Mexoeiro
Vigo, Spain
Hospital Galdakao
Vizcaya, Spain
Switzerland
Clinique Cecil
Lausanne, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
University Hospital Zürich
Zürich, Switzerland
Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Raimund Erbel, MD Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany
  More Information

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01056120     History of Changes
Other Study ID Numbers: C0903
Study First Received: January 25, 2010
Last Updated: August 8, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on July 31, 2014