UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033709 |
|---|---|
| Receipt number | R000037079 |
| Scientific Title | Prospective randomized trial comparing paclitaxel releasing balloon with everolimus eluting stent for the small coronary vessels |
| Date of disclosure of the study information | 2018/08/15 |
| Last modified on | 2018/08/10 11:41:20 |
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Basic information
Public title
Prospective randomized trial comparing paclitaxel releasing balloon with everolimus eluting stent for the small coronary vessels
Acronym
ORB study
Scientific Title
Prospective randomized trial comparing paclitaxel releasing balloon with everolimus eluting stent for the small coronary vessels
Scientific Title:Acronym
ORB study
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the noninferiority efficacy of drug-coating balloons(DCB) compared with everolimus eluting stents(EES) for coronary artery
disease in small vessels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
percentage diameter stenosis of the target vessel at follow up angiography
Key secondary outcomes
all cause death acute coronary syndrome revascularization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
drug coating balloon
follow up duration 12 months
follow up angiogram will be performed after 8months from initial therapy
Interventions/Control_2
everolimous eluting stent
follow up duration 12 months
follow up angiogram will be performed after 8months from initial therapy
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with coronary artery disease less than 2.75mm in diameter
Key exclusion criteria
Acute coronary syndrome
heart failure
person requiring dialysis
pregnant women
in stent restenosis case
severe calcified vessel
contraindicated to antiplatelet therapy
Target sample size
322
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tamura |
Organization
The Juntendo University Nerima Hospital
Division name
Department of Cardiology
Zip code
Address
3-1-10 Takanodai Nerima-ku, Tokyo
TEL
03-5923-3111
tamura5155@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tamura |
Organization
The Juntendo University Nerima Hospital
Division name
Department of Cardiology
Zip code
Address
3-1-10 Takanodai Nerima-ku, Tokyo
TEL
03-5923-3111
Homepage URL
tamura5155@gmail.com
Sponsor or person
Institute
The Juntendo University Nerima Hospital
Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
順天堂大学医学部附属練馬病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 10 | Day |
Last modified on
| 2018 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037079
