Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fujita Health University | OTHER |
| Erasmus Medical Center | OTHER |
| Terumo Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D OFDI guidance arm | Experimental | Bifurcation percutaneous coronary intervention (PCI) optimized by online-3D OFDI during and after procedure |
|
| Angio guidance arm | Active Comparator | Bifurcation percutaneous coronary intervention (PCI) guided by angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D OFDI guidance arm | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of malapposed struts | Percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel | at time of bifurcation PCI surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of fulfilling optimal recrossing criteria on 3D-OFDI | Measured as a percentage | at time of bifurcation PCI surgery |
| Incomplete stent apposition (ISA) area (mm²) | at time of bifurcation PCI surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoshinobu Onuma | Contact | (011)+31-10-704-0704 | yoshinobuonuma@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yoshinobu Onuma | Fujita Health University/Erasmus University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujita Health University | Toyoake | Aichi-ken | 470-1192 | Japan | ||
| Erasmus University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25256198 | Background | Lassen JF, Holm NR, Stankovic G, Lefevre T, Chieffo A, Hildick-Smith D, Pan M, Darremont O, Albiero R, Ferenc M, Louvard Y. Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention. 2014 Sep;10(5):545-60. doi: 10.4244/EIJV10I5A97. | |
| 23714592 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Angio guidance arm | Device | 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. |
|
| 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 |
| Mean stent area (mm²) | at time of bifurcation PCI surgery |
| 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 |
| Rotterdam |
| South Holland |
| 3015 CE |
| Netherlands |
| Foin N, Torii R, Alegria E, Sen S, Petraco R, Nijjer S, Ghione M, Davies JE, Di Mario C. Location of side branch access critically affects results in bifurcation stenting: Insights from bench modeling and computational flow simulation. Int J Cardiol. 2013 Oct 9;168(4):3623-8. doi: 10.1016/j.ijcard.2013.05.036. Epub 2013 May 25. |
| 22581489 | Background | Alegria-Barrero E, Foin N, Chan PH, Syrseloudis D, Lindsay AC, Dimopolous K, Alonso-Gonzalez R, Viceconte N, De Silva R, Di Mario C. Optical coherence tomography for guidance of distal cell recrossing in bifurcation stenting: choosing the right cell matters. EuroIntervention. 2012 Jun 20;8(2):205-13. doi: 10.4244/EIJV8I2A34. |
| 22334321 | Background | Okamura T, Onuma Y, Garcia-Garcia HM, Bruining N, Serruys PW. High-speed intracoronary optical frequency domain imaging: implications for three-dimensional reconstruction and quantitative analysis. EuroIntervention. 2012 Feb;7(10):1216-26. doi: 10.4244/EIJV7I10A194. |
| 24531393 | Background | Okamura T, Onuma Y, Yamada J, Iqbal J, Tateishi H, Nao T, Oda T, Maeda T, Nakamura T, Miura T, Yano M, Serruys PW. 3D optical coherence tomography: new insights into the process of optimal rewiring of side branches during bifurcational stenting. EuroIntervention. 2014 Dec;10(8):907-15. doi: 10.4244/EIJV10I8A157. |
| 33272034 | Derived | Onuma Y, Kogame N, Sotomi Y, Miyazaki Y, Asano T, Takahashi K, Kawashima H, Ono M, Katagiri Y, Kyono H, Nakatani S, Muramatsu T, Sharif F, Ozaki Y, Serruys PW, Okamura T; OPTIMUM Investigators. A Randomized Trial Evaluating Online 3-Dimensional Optical Frequency Domain Imaging-Guided Percutaneous Coronary Intervention in Bifurcation Lesions. Circ Cardiovasc Interv. 2020 Dec;13(12):e009183. doi: 10.1161/CIRCINTERVENTIONS.120.009183. Epub 2020 Dec 4. |
| 31289018 | Derived | Miyazaki Y, Muramatsu T, Asano T, Katagiri Y, Sotomi Y, Nakatani S, Takahashi K, Kogame N, Higuchi Y, Ishikawa M, Kyono H, Yano M, Ozaki Y, Serruys PW, Okamura T, Onuma Y. Online three-dimensional OFDI-guided versus angiography-guided PCI in bifurcation lesions: design and rationale of the randomised OPTIMUM trial. EuroIntervention. 2021 Mar 19;16(16):1333-1341. doi: 10.4244/EIJ-D-18-00902. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |