UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027068
Receipt number 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 2022/04/25 09:11:51

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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 Satoaki
Middle name
Last name Matoba

Organization

Kyoto Prefectural University of Medicine

Division name

Cardiology

Zip code

6028566

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 Naohiko
Middle name
Last name Nakanishi

Organization

Kyoto Prefectural University of Medicine

Division name

Cardiology

Zip code

6028566

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 or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



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

Kyoto Prefectural University of Medicine

Address

465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ward Kyoto 602-8566, Japan

Tel

075-251-5337

Email

rinri@koto.kpu-m.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 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

Terminated

Date of protocol fixation

2017 Year 03 Month 31 Day

Date of IRB

2017 Year 08 Month 08 Day

Anticipated trial start date

2017 Year 06 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

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

2022 Year 04 Month 25 Day



Link to view the page

Value
https://center6.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