UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024847
Receipt number R000028594
Scientific Title On-line 3-dimensional OPTical frequency domain IMaging to optimize bifurcation stenting using UltiMaster stent
Date of disclosure of the study information 2017/01/01
Last modified on 2021/07/30 04:08:20

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Basic information

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

Condition

coronary artery disease, bifurcation lesion

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

Primary outcomes

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

Key secondary outcomes



Base

Study type

Interventional


Study design

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


Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Meditrix Corporation

Institute

Department

Personal name



Funding Source

Organization

TERUMO CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 Day


Related information

URL releasing protocol

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

Publication of results

Published


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name