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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024847
Receipt No. 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 2019/01/07

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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
Middle name
Last name Yoshinobu Onuma
Organization FUJITA HEALTH UNIVERSITY/Erasmus University Medical Center
Division name Cadiology
Zip code
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
Middle name
Last name Yoshinobu Onuma
Organization FUJITA HEALTH UNIVERSITY/Erasmus University Medical Center
Division name Cadiology
Zip code
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
Institute Meditrix Corporation
Institute
Department

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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
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
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.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


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