Coronary artery disease requiring percutaneous coronary intervention (PCI) for coronary artery lesions with severe calcification
Conditions
Interventions
None listed
Sponsors
YOKOHAMA CITY UNIVERSITY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patient with coronary artery disease requiring PCI (2) Patient with moderate to severe calcification as detected by angiography (3) Patient who will undergo balloon dilatation followed by stent implantation. (4) Patients with lesion(s) observed by OCT both after balloon dilatation and after stent implantation (5) Patient who has personally given written informed consent
Exclusion criteria
Exclusion criteria: (1) Culprit lesion(s) for ST elevation acute myocardial infarction (2) Patient with cardiogenic shock (3) Patient with acute decompensated heart failure (4) Graft lesion or in-stent restenotic lesion (5) Patient who has no indication for stent implantation (6) Patient with chronic kidney disease who is not receiving dialysis therapy (serum Cr > 2 mg/dL) (7) Lesion at the orifice of the left main trunk or the orifice of the right coronary artery (8) Female patient who is pregnant or plans to become pregnant (9) Patient who is deemed otherwise unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of calcium crack after balloon dilatation and final stent area as assessed by OCT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Parameters analyzed by OCT (1) Before PCI (in patients capable of undergoing OCT) Calcification arc, calcification thickness, minimal lumen area (2) After Rotational atherectomy (only in patients underwent Rotational atherectomy) Calcification arc, calcification thickness, minimal lumen area (3) After balloon dilatation Presence of calcium crfack, presence of coronary artery dissection (4) After stent implantation Stent area, stent asymmetry index (minimum diameter/maximum diameter), presence of incomplete stent apposition, area of incomplete stent apposition Outcome at 1 year (1) Mortality (2) Non-fatal myocardial infarctions (3) Stent thrombosis (4) Binary restenosis (5) Target lesion revascularization (6) Target vessel revascularization (7) Composite endpoint including (1), (2), and (6) above Exploratory parameter An exploratory study of the correlation of platelet aggregation activity and CYP2C19 gene polymorphism with event occurrence | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactNobuhiko Maejima
YOKOHAMA CITY UNIVERSITY MEDICAL CENTER Cardiovascular Center
Outcome results
None listed