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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: October 4, 2011
Last verified: October 2011
History of Changes

January 25, 2010
October 4, 2011
March 2010
February 2013   (final data collection date for primary outcome measure)
MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01056120 on ClinicalTrials.gov Archive Site
• 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 ]
Same as current
Not Provided
Not Provided
 
Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Community sample
De Novo and Re-stenosed Coronary Artery Lesions
Device: Pro Kinetic Energy bare metal stent
PCI
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.

Intervention: Device: Pro Kinetic Energy bare metal stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1026
February 2013
February 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Ireland,   Israel,   Latvia,   Netherlands,   Spain,   Switzerland
 
NCT01056120
C0903
No
Biotronik AG
Biotronik AG
Not Provided
Principal Investigator: Raimund Erbel, MD Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany
Biotronik AG
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP