UMIN-CTR Clinical Trial

Public title

On-line 3-dimensional OPTical frequency domain IMaging to optimize bifurcation stenting using UltiMaster stent

Acronym

OPTIMUM

Scientific Title

On-line 3-dimensional OPTical frequency domain IMaging to optimize bifurcation stenting using UltiMaster stent

Scientific Title:Acronym

OPTIMUM

Region

Japan

Europe

Condition

coronary artery disease, bifurcation lesion

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the superiority of On-line 3-dimensional optical frequency domain imaging (3D-OFDI) in coronary bifurcation lesions

Basic objectives2

Others

Basic objectives -Others

speriority

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase IV

Primary outcomes

Post-procedural percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Bifurcation PCI optimized by online-3D OFDI during and after procedure

Interventions/Control_2

Bifurcation PCI guided by angiography

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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

Key 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

Target sample size

106

Name of lead principal investigator

1st name	Yoshinobu
Middle name
Last name	Onuma

Organization

FUJITA HEALTH UNIVERSITY/Erasmus University Medical Center

Division name

Cadiology

Zip code

470-1192

Address

1-98 dengakugakubo, Kutsukake-cho, toyoake, Aichi Japan/'s-Gravendijkwal 230 3015 CE Rotterdam

TEL

+31-10-704-0704

Email

yoshinobuonuma@gmail.com

Name of contact person

1st name	Yoshinobu
Middle name
Last name	Onuma

Organization

FUJITA HEALTH UNIVERSITY/Erasmus University Medical Center

Division name

Cadiology

Zip code

470-1192

Address

1-98 dengakugakubo, Kutsukake-cho, toyoake, Aichi Japan/'s-Gravendijkwal 230 3015 CE Rotterdam

TEL

+31-10-704-0704

Homepage URL

Email

yoshinobuonuma@gmail.com

Institute

Meditrix Corporation

Institute

Department

Personal name

Organization

TERUMO CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fujita Health University Certified Clinical Research Review Board

Address

1-98, Dengakugakubo, Kutukake, Toyoake, Japan, Aichi

Tel

0562-93-2865

Email

f-irb@fujita-hu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

01

Month

01

Day

URL releasing protocol

https://jrct.niph.go.jp/latest-detail/jRCTs042180022

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/33272034/

Number of participants that the trial has enrolled

110

Results

a primary endpoint was significantly reduced by about 30% in the OFDI arm, and the metallic carina in the bifurcation was significantly less frequently observed in the OFDI arm .
The feasibility of 3D-OFDI was considerably high (98%), and approximately 60% of the patients were able to achieve an optimal wire re-crossing in the first attempt. It was finally achieved in all cases in the OFDI arm.
There was no significant difference in radiocontrast volume during the procedure between the two arms.

Results date posted

2021

Year

07

Month

30

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Mean age was 69 years and approximately half of the patients were DM. ACS was less than 10%, and a vast majority was classified as stable angina. LMT or LAD-Dx (LM 8%) bifurcation was treated in 70% of cases. True bifurcation was observed in 14% of the OFDI arm vs 6% of the Angio arm (p=0.14).
POT was performed in almost all (98%) of the cases.

Participant flow

A total of 106 patients (56 in the OFDI arm and 54 in the Angio arm) were enrolled from October 2016 to March 2018

Adverse events

There were no device failures or device-related adverse events, but there was 1 bleeding event (subcutaneous hemorrhage at the puncture site [Angio arm]), 12 cardiovascular events including 1 cerebral infarction (OFDI arm), 1 TIA (Angio arm), or 10 unplanned PCIs (7 OFDI arm and 3 Angio arm), and 1 death (OFDI arm).
The main cause of the death was TAVI valve infection and sepsis at 6 weeks after PCI.

Outcome measures

Post-procedural percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

06

Month

22

Day

Date of IRB

2016

Year

09

Month

09

Day

Anticipated trial start date

2017

Year

01

Month

01

Day

Last follow-up date

2019

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

11

Month

15

Day

Last modified on

2021

Year

07

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028594