UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036420
Receipt number R000041493
Scientific Title Novel DCB for Coronary Artery Disease Trial
Date of disclosure of the study information 2019/04/05
Last modified on 2023/10/10 10:53:11

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Basic information

Public title

Novel DCB for Coronary Artery Disease Trial

Acronym

Novel DCB Trial

Scientific Title

Novel DCB for Coronary Artery Disease Trial

Scientific Title:Acronym

Novel DCB Trial

Region

Japan


Condition

Condition

Coronary Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of novel DCB for CAD patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

MACE 12 Months

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Up to 3 pcs for 1 patient

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


Not applicable

Gender

Male and Female

Key inclusion criteria

- Male and female over 20 years old
- Patients with CAD as class II of CCS
- Patients with proven ischemia in coronary artery
- Patients who can be treated with PCI or CABG

Key exclusion criteria

- Female during pregnancy
- Patients with creatinine level over 2.0mg/dl
- Patients with liver dysfunction
- Patients under evaluation for other clinical trials

Target sample size

220


Research contact person

Name of lead principal investigator

1st name Norikazu
Middle name
Last name Iwamoto

Organization

Zeon Medical Inc.

Division name

Business Development Department

Zip code

1000005

Address

Shin Marunouchi Center Bldg, 1-6-2 Marunouchi, Chiyoda-ku, Tokyo

TEL

03-3216-1267

Email

N2.Iwamoto@zeon.co.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Oishi

Organization

Zeon Medical Inc.

Division name

Business Development Department

Zip code

1000005

Address

Shin Marunouchi Center Bldg, 1-6-2 Marunouchi, Chiyoda-ku, Tokyo

TEL

03-3216-1267

Homepage URL


Email

Y.Oishi@zeon.co.jp


Sponsor or person

Institute

Zeon Medical Inc.
Business Development Depertment

Institute

Department

Personal name



Funding Source

Organization

Zeon Medical Inc.
Business Development Depertment

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

Zeon Medical Inc.

Address

Shin Marunouchi Center Bldg, 1-6-2 Marunouchi, Chiyoda-ku, Tokyo

Tel

03-3216-1267

Email

Y.Oishi@zeon.co.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

2019 Year 04 Month 05 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

Completed

Date of protocol fixation

2019 Year 03 Month 02 Day

Date of IRB

2019 Year 01 Month 31 Day

Anticipated trial start date

2019 Year 04 Month 08 Day

Last follow-up date

2022 Year 05 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

2019 Year 04 Month 05 Day

Last modified on

2023 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041493


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name