Using 3D Imaging to Optimize Bifurcation Stenting

On-line 3-dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent: OPTIMUM Study

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Bifurcation Lesion
• Intervention / Treatment: Device: 3D OFDI guidance arm; Device: Angio guidance arm

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.

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Aichi Prefecture
    • Toyoake, Aichi Prefecture, Japan, 470-1192
      • Fujita Health University
• Netherlands
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 CE
      • Erasmus University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D OFDI guidance arm; Bifurcation percutaneous coronary intervention (PCI) optimized by online-3D OFDI during and after procedure	Device: 3D 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.
Active Comparator: Angio guidance arm; Bifurcation percutaneous coronary intervention (PCI) guided by angiography	Device: Angio 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Increase Co., Ltd.
• Collaborators: Erasmus Medical Center; Terumo Corporation; Fujita Health University
• Investigators: Principal Investigator: Yoshinobu Onuma, Fujita Health University/Erasmus University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: OPTI001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO