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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
  Purpose

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.


Condition Intervention
De Novo and Re-stenosed Coronary Artery Lesions
 Device: Pro Kinetic Energy bare metal stent

Study Type: Observational
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

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • 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 ]

Enrollment: 1026
Study Start Date: March 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

 Device: Pro Kinetic Energy bare metal stent
PCI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056120

  Show 50 Study Locations
Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Raimund Erbel, MD Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany
  More Information

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01056120     History of Changes
Other Study ID Numbers: C0903
Study First Received: January 25, 2010
Last Updated: October 4, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 19, 2013