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OpenTrials
Completed

NCT Number: NCT01056120

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

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.

Completed

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Key information

Conditions

De Novo and Re-stenosed Coronary Artery Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Landeskrankenhaus Bruck an der Mur, Bruck an der Mur, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pro Kinetic Energy bare metal stent

Device

PCI

Primary outcomes

  1. MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI)

    Time frame: 6 months

Secondary outcomes

  1. • 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

Sponsors and collaborators

Lead sponsor

Biotronik AG

Industry

Registry information

Official study 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

Acronym: ENERGY

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 26, 2010
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.