Overview

This trial is active, not recruiting.

Condition de novo and re-stenosed coronary artery lesions
Treatment pro kinetic energy bare metal stent
Sponsor Biotronik AG
Start date March 2010
End date February 2013
Trial size 1026 participants
Trial identifier NCT01056120, C0903

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
pro kinetic energy bare metal stent
PCI

Primary Outcomes

Measure
MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI)
time frame: 6 months

Secondary Outcomes

Measure
• 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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Principal investigator Raimund Erbel, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Biotronik AG.