Coronary Artery Disease
Conditions
Keywords
Chronic total occlusion, Bifurcation lesion, Left main trunk lesion, Small vessel disease, Multi vessel disease
Brief summary
Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.
Interventions
DEVICEplatinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)
Sponsors
The PCI Guideline Research Society
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome 2. Male or non-pregnant female 3. 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
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 | 12 month |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion revascularization | 12 month |
| Target vessel revascularization | 12 month |
| Myocardial infarction | 24 month |
| Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site | In hospital |
| Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization | 24 month |
| Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC) | 24 month |
| Cardiac death | 24 month |
Countries
Japan
Contacts
Primary ContactKenya Nasu, MD, FACC
Backup ContactYuji Oikawa, MD,PｈD
Outcome results
None listed