Calcified lesion
Conditions
Interventions
Bioresorbable vascular scaffold (BVS)
Calcified
Coronary artery disease
Follow up
Invasive Imaging
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: *To be eligible for this study the subject has to be treated for a de novo stenotic, moderate - severely calcified coronary lesion with the BVS in the Erasmus MC and be included in the BVS Expand Registry *Patient is able to verbally confirm understanding of risks, benefits of the BVS calcified study and he/ she or his/ hers legally authorized representative provides written consent informed consent prior to any clinical investigation related procedure, as approves by the appropriate Ethics Committee of the respective clinical site *18 years and above
Exclusion criteria
Exclusion criteria: - Previous CABG - Cardiogenic shock - Known hypersensitivity or contra-indication to treatment with heparin or contrast that cannot be adequately pre-medicated - Known renal insufficiency (Creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameters for our study are: the scaffold apposition, the strut coverage, the lumen enlargement, the late lumen loss, the mean and minimum lumen scaffold area, the stent area and the vessel area. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are clinical outcomes including death, myocardial infarction, target lesion revascularization and scaffold thrombosis. | — |
Countries
The Netherlands
Outcome results
None listed