Using 3D Imaging to Optimize Bifurcation Stenting

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2016
• Main ID: NCT02972489
• Date of registration: 14/11/2016
• Prospective Registration: Yes
• Primary sponsor: Increase Co., Ltd.
• Public title: Using 3D Imaging to Optimize Bifurcation Stenting
• Scientific title: On-line 3-dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent: OPTIMUM Study
• Date of first enrolment: January 2017
• Target sample size: 106
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02972489
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Japan, Netherlands

Contacts

• Name: Yoshinobu Onuma
• Affiliation: Fujita Health University/Erasmus University Medical Center

• Name: Yoshinobu Onuma

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Bifurcation Lesion

Intervention(s)

Device: Angio guidance arm

Device: 3D OFDI guidance arm

Primary Outcome(s)

Percentage of malapposed struts [Time Frame: at time of bifurcation PCI surgery]

Secondary Outcome(s)

Minimum lumen area (mm²) [Time Frame: at time of bifurcation PCI surgery]

Mean stent area (mm²) [Time Frame: at time of bifurcation PCI surgery]

Incomplete stent apposition (ISA) area (mm²) [Time Frame: at time of bifurcation PCI surgery]

Mean flow area (mm²) [Time Frame: at time of bifurcation PCI surgery]

Maximum protrusion area (mm²) [Time Frame: at time of bifurcation PCI surgery]

Mean lumen area (mm²) [Time Frame: at time of bifurcation PCI surgery]

Minimum stent area (mm²) [Time Frame: at time of bifurcation PCI surgery]

Mean protrusion area (mm²) [Time Frame: at time of bifurcation PCI surgery]

Incidence of fulfilling optimal recrossing criteria on 3D-OFDI [Time Frame: at time of bifurcation PCI surgery]

Minimum flow area (mm²) [Time Frame: at time of bifurcation PCI surgery]

Secondary ID(s)

OPTI001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fujita Health University

Terumo Corporation

Erasmus Medical Center