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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01056120
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

Tracking Information
First Submitted Date January 25, 2010
First Posted Date January 26, 2010
Last Update Posted Date February 1, 2016
Study Start Date March 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2010)
MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01056120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 25, 2010)
• 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice
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
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community sample
Condition De Novo and Re-stenosed Coronary Artery Lesions
Intervention Device: Pro Kinetic Energy bare metal stent
PCI
Study Groups/Cohorts 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 4, 2011)
1026
Original Estimated Enrollment
 (submitted: January 25, 2010)
1000
Actual Study Completion Date December 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   France,   Germany,   Ireland,   Israel,   Latvia,   Netherlands,   Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01056120
Other Study ID Numbers C0903
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biotronik AG
Study Sponsor Biotronik AG
Collaborators Not Provided
Investigators
Principal Investigator: Raimund Erbel, MD Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany
PRS Account Biotronik AG
Verification Date January 2016