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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027068
Receipt No. R000031029
Scientific Title Prediction of slow-flow phenomenon during coronary rotational atherectomy by near-infrared spectroscopy
Date of disclosure of the study information 2017/04/20
Last modified on 2017/04/19

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Basic information
Public title Prediction of slow-flow phenomenon during coronary rotational atherectomy by near-infrared spectroscopy
Acronym Prediction of slow-flow phenomenon during coronary rotational atherectomy by near-infrared spectroscopy
Scientific Title Prediction of slow-flow phenomenon during coronary rotational atherectomy by near-infrared spectroscopy
Scientific Title:Acronym Prediction of slow-flow phenomenon during coronary rotational atherectomy by near-infrared spectroscopy
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To predict the slow-flow phenomenon during coronary rotational atherectomy by near-infrared spectroscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of lipid core burden index evaluated by near-infrared spectroscopy in the calcified plaque with slow-flow phenomenon
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We use near-infrared spectroscopy (NIRS-IVUS) during coronary rotational atherectomy.
Interventions/Control_2
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with superficial calcification in the coronary artery evaluated by NIRS-IVUS during percutaneous coronary intervention with rotational atherectomy
Key exclusion criteria Patients with acute coronary syndrome, intolerance to anti-coagulant and anti-platelet therapy, not crossing the NIRS-IVUS, severe complication (severe liver dysfunction, severe renal failure, uncontrolled hypertension), and unstable hemodynamics
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoaki Matoba
Organization Kyoto Prefectural University of Medicine
Division name Cardiology
Zip code
Address 465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ward Kyoto 602-8566, Japan
TEL 075-251-5511
Email matoba@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohiko Nakanishi
Organization Kyoto Prefectural University of Medicine
Division name Cardiology
Zip code
Address 465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ward Kyoto 602-8566, Japan
TEL 075-251-5511
Homepage URL
Email naka-nao@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
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 04 Month 20 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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
2017 Year 04 Month 19 Day
Last modified on
2017 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031029

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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