Coronary Artery Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) All patients should be over 18 years of age. 2) Patients with stable coronary artery disease must have a clinical indication for percutaneous coronary intervention. 3) The target lesion must be a de novo calcified lesion that has calcification more than 180 degree of arc assessed by OCT. 4) Moderate or severe calcification by angiogram, if OCT does not cross the lesion.
Exclusion criteria
Exclusion criteria: 1)Ostial left main artery or ostial right coronary artery lesions. 2)Female patients of childbearing potential. 3)Life expectancy less than 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tissue modification and stent outcomes assessed by OCT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedural complications (coronary artery perforation, slow/no flow, dissections during procedure and peri-procedural myocardial infarction) and procedural time and contrast volume. Major adverse cardiovascular events at 8 months after the procedure | — |
Countries
Japan
Contacts
Osaka Rosai Hospital Cardiology