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

Biotronik

Status: Completed

Conditions: De Novo and Re-stenosed Coronary Artery Lesions

Treatments: Device: Pro Kinetic Energy bare metal stent

Study type: Observational

Funder types: Industry

Identifiers

NCT01056120

C0903

Details and patient eligibility

About

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.

Enrollment: 1,026 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,026 participants in 1 patient group

ENERGY-Population

Description:

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.

Treatment:

Device: Pro Kinetic Energy bare metal stent