Bifurcation Lesion, Coronary Artery Disease
Conditions
Brief summary
The primary purpose of this study is to determine whether bifurcation stenting guided by on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation segment.
Detailed description
The recently developed optical frequency domain imaging (OFDI) can provide high quality resolution images of the coronary arteries. This new imaging system enhances the understanding of complex coronary lesions and the complex interaction between coronary devices and vessels by assembling/compiling 2-dimensional cross sections. This 3-dimensional reconstruction with strut segmentation becomes possible on-line in the TERUMO OFDI console with 3-dimensional imaging software, which enables stent enhancement and 3D reconstruction within one minute. This real time 3D OFDI will promote the utilisation of 3-dimensional assessment in the treatment of bifurcation lesions.
Interventions
DEVICE3D OFDI guidance arm
Subjects randomized to 3D-guidance arm will undergo optical frequency domain imaging (OFDI) assessment in the main vessel after re-wiring into the jailed side branch following stent implantation. If the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm position in 2D and off-line 3D reconstruction. After procedure, OFDI is performed in the main branch.
DEVICEAngio guidance arm
In angiography-guidance group, wire recrossing into the side branch will be performed using conventional fluoroscopic/angiographic guidance. After finishing the procedure, OFDI is performed in the main branch but the results will be blinded to the operators.
Sponsors
Fujita Health University
Erasmus Medical Center
Terumo Corporation
Increase Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 non-ST segment elevation acute coronary syndrome (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
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. Other: Patient is judged inappropriate by the attending physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of malapposed struts | at time of bifurcation PCI surgery | Percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incomplete stent apposition (ISA) area (mm²) | at time of bifurcation PCI surgery | — |
| Minimum lumen area (mm²) | at time of bifurcation PCI surgery | — |
| Mean lumen area (mm²) | at time of bifurcation PCI surgery | — |
| Minimum stent area (mm²) | at time of bifurcation PCI surgery | — |
| Incidence of fulfilling optimal recrossing criteria on 3D-OFDI | at time of bifurcation PCI surgery | Measured as a percentage |
| Mean protrusion area (mm²) | at time of bifurcation PCI surgery | — |
| Maximum protrusion area (mm²) | at time of bifurcation PCI surgery | — |
| Minimum flow area (mm²) | at time of bifurcation PCI surgery | — |
| Mean flow area (mm²) | at time of bifurcation PCI surgery | — |
| Mean stent area (mm²) | at time of bifurcation PCI surgery | — |
Countries
Japan, Netherlands
Contacts
Primary ContactYoshinobu Onuma
Outcome results
None listed