An observational study in De Novo and Re-stenosed Coronary Artery Lesions, sponsored by Biotronik AG. Completed at 50 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-01.
Sponsored by Biotronik AG · Observational
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.
Biotronik AG is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Community sample
Exclusion Criteria:
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
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
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Biotronik AG