coronary artery disease, bifurcation lesion
Conditions
Interventions
Bifurcation PCI optimized by online-3D OFDI during and after procedure
Bifurcation PCI guided by angiography
Sponsors
Meditrix Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is at least 18 years of age and signed Informed Consent 2. Subject has coronary artery disease involving a bifurcation with objective evidence of ischemia including patients with chronic stable angina, silent ischemia and NSTE-ACS 3. Subject is appropriate to be treated by PCI according to the local practice (operator's judgment or heart team decision) 4. Patients residence is in the area covered by the hospital 5. Patients with angiographically significant stenosis (>50 % by visual assessment) in de novo, native, previously unstented bifurcation lesion(s) including left main lesion, which is in operator's opinion appropriate to be treated by PCI with a single stent strategy 6. The size of main vessel matches available Ultimaster stent sizes (<4.0 mm, and 2.0 mm by visual assessment). 7. The size of side branch is >2.0mm in diameter by visual assessment. 8. The sidebranch is treatable with a sidebranch fenestration and/or kissing balloon
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Patients with ST elevation myocardial infarction 3. Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, sirolimus, contrast material 4. Known thrombocytopenia (platelet count< 100,000/mm3) 5. Cardiogenic Shock 6. Significant comorbidities precluding clinical follow-up (as judged by investigators) 7. Major planned surgery that requires discontinuation of dual antiplatelet therapy 8. History of stenting in the target bifurcation lesion 9. Renal insufficiency (GFR/MDRD <45 ml/min), which precludes in operator's opinion contrast injection during repeat OFDI pullback 10. Severely tortuous or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal optical frequency domain imaging (OFDI) or excessive risk of complication to place an OFDI catheter. 11. Target lesion reference vessel diameter (RVD) < 2.25 and > 4 mm 12. Others, Patient judged inappropriate by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-procedural percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel | — |
Countries
Japan,Europe
Contacts
Public ContactYoshinobu Onuma
FUJITA HEALTH UNIVERSITY/Erasmus University Medical Center Cadiology
Outcome results
None listed