UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038451 |
|---|---|
| Receipt number | R000043816 |
| Scientific Title | Atherosclerotic Complex coronary Artery Diseases treated by Zotarolimus-Eluting Resolute Onyx stent ~A multi-center registry~ |
| Date of disclosure of the study information | 2019/10/31 |
| Last modified on | 2019/11/01 17:19:34 |
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Basic information
Public title
Atherosclerotic Complex coronary Artery Diseases treated by Zotarolimus-Eluting Resolute Onyx stent ~A multi-center registry~
Acronym
ARCADIA ZERO
Scientific Title
Atherosclerotic Complex coronary Artery Diseases treated by Zotarolimus-Eluting Resolute Onyx stent ~A multi-center registry~
Scientific Title:Acronym
ARCADIA ZERO
Region
| Japan |
Condition
Condition
Atherosclerotic complex coronary artery diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the clinical efficacy and safety of onyx stent in the daily clinical practice in Japan when using Onyx to treat complex lesions with coronary atherosclerosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of target lesion failure (TLF) within 12 months after Onyx coronary stenting.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
-
Key exclusion criteria
-
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Nasu |
Organization
Toyohashi Heart Center
Division name
Cardiovascular Medicine
Zip code
441-8530
Address
21-1,Gobundori,yama-Cho,Toyohashi,Aichi,Japan
TEL
0532-37-3377
nasu@heart-center.or.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Akashi |
Organization
CV Quest Co.,Ltd
Division name
Clinical Research Support
Zip code
107-0062
Address
3-B,6-13-9 Minamiaoyama,Minato-ku,Tokyo,Japan
TEL
03-6427-9947
Homepage URL
arcadia@cvq.co.jp
Sponsor or person
Institute
Toyohashi Heart Center
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co.,Ltd.
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
Toyohashi Heart Center
Address
21-1,Gobundori,yama-Cho,Toyohashi,Aichi,Japan
Tel
0532-37-3377
nasu@heart-center.or.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
心臓血管研究所附属病院（東京都）他
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
-
Management information
Registered date
| 2019 | Year | 10 | Month | 31 | Day |
Last modified on
| 2019 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043816
