Complex coronary artery disease
Conditions
Interventions
Sponsors
The PCI Guideline Research Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Ischemic heart disease including stable angina pectoris and acute coronary syndrome b. Male or non-pregnant female c. Key lesion inclusion criteria as follows (1) Multi-vessel diseases (2) Long lesion (lesion length >30mm by visual estimation) (3) Small vessel disease (reference diameter <2.5mm by visual estimation) (4) Bifurcation lesion (5) Ostial lesion (6) Calcified lesion (7) Protected or non-protected left main trunk disease (8) Chronic total occlusion (9) In stent restenosis of bare metal stent or everolimus-eluting stent
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media. 2) Serum creatinine level >3.0 mg/dL 3) Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization at 12 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| a.Procedural success b.Target lesion revascularization at 12 month c.TVR at 12 month d.MI at 24 month e.Death at 24 month f.MACE at 24 month g.Stent thrombosis (acute, sub-acute, late,and very late) definited by Academic Research Consortium (ARC) at 24 month | — |
Countries
Japan
Contacts
Public ContactKenya Nasu
Toyohashi Heart Center Cardiology
Outcome results
None listed