Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice (ENERGY)
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|ClinicalTrials.gov Identifier: NCT01056120|
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : February 1, 2016
|Condition or disease||Intervention/treatment|
|De Novo and Re-stenosed Coronary Artery Lesions||Device: Pro Kinetic Energy bare metal stent|
|Study Type :||Observational|
|Actual Enrollment :||1026 participants|
|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|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||December 2013|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056120
|Principal Investigator:||Raimund Erbel, MD||Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany|