De Novo and Re-stenosed Coronary Artery Lesions
Conditions
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.
Interventions
DEVICEPro Kinetic Energy bare metal stent
PCI
Sponsors
Biotronik AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| • 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) | 6,12, 24 Months |
Countries
Austria, Belgium, France, Germany, Ireland, Israel, Latvia, Netherlands, Spain, Switzerland
Outcome results
None listed