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
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
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
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/icdr_e/ctr_view.cgi?recptno=R000041493
