UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019105 |
|---|---|
| Receipt number | R000022089 |
| Scientific Title | PROspective randomized study to evaluate Proximal Optimization Technique in coronary bifurcation lesions |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2021/09/15 13:46:52 |
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Basic information
Public title
PROspective randomized study to evaluate Proximal Optimization Technique in coronary bifurcation lesions
Acronym
PROPOT
Scientific Title
PROspective randomized study to evaluate Proximal Optimization Technique in coronary bifurcation lesions
Scientific Title:Acronym
PROPOT
Region
| Japan | Europe |
Condition
Condition
coronary artery disease, bifurcation lesion
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the proximal optimization technique (POT) in coronary bifurcation lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of apposed stent struts (%) by OCT immediately after the procedure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
POT technique group
Interventions/Control_2
non-POT technique group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Bifurcation lesions with a side branch of 2.0 mm that can be identified by CAG
Bifurcation lesions that can be treated by provisional side branch stenting
No remote lesions in the same vessel with the target lesion
New lesions or restenotic lesions without a stent implanted
Lesions in which stenting is feasible; the visually estimated reference diameter of the main vessel is over 2.5 mm; if two or more bifurcation lesions are found in the reference lesion, the proximal lesion will be studied.
Key exclusion criteria
Contraindications to antiplatelet drugs/anticoagulant drugs
Significant allergic reactions to contrast agents
EF <30%
Graft lesions
In-stent restenotic lesions
Chronic total occlusion
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Watanabe |
Organization
Teikyo university school of Medicine
Division name
Cardiology
Zip code
Address
2-11-1 kaga itabashi-ku Tokyo Japan
TEL
03-3964-1211
yusuke0831@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Watanabe |
Organization
Teikyo university school of medicine
Division name
Cardiology
Zip code
Address
2-11-1 kaga itabashi-ku Tokyo Japan
TEL
03-3964-1211
Homepage URL
yusuke0831@gmail.com
Sponsor or person
Institute
Increase, Co Japan
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan, CO
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 01 | 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
| 2015 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 24 | Day |
Last modified on
| 2021 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022089
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
