Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice (ENERGY)
|De Novo and Re-stenosed Coronary Artery Lesions||Device: Pro Kinetic Energy bare metal stent|
|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|
- MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) [ Time Frame: 6 months ]
- • 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 ]
|Study Start Date:||March 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056120
Show 50 Study Locations
|Principal Investigator:||Raimund Erbel, MD||Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany|