UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014749 |
|---|---|
| Receipt number | R000016219 |
| Scientific Title | A 3D-OCT investigation into coronary artery bifurcation lesion stent implantation technique |
| Date of disclosure of the study information | 2014/08/04 |
| Last modified on | 2021/08/09 14:19:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A 3D-OCT investigation into coronary artery bifurcation lesion stent implantation technique
Acronym
3D-OCT Bifurcation Registry
Scientific Title
A 3D-OCT investigation into coronary artery bifurcation lesion stent implantation technique
Scientific Title:Acronym
3D-OCT Bifurcation Registry
Region
| Japan |
Condition
Condition
Coronary artery bifurcation disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the optimal position of guide wire recrossing into jailed strut after stent deployment and demonstrate difficulties of bifurcation stenting utilizing 2D-/3D-OCT imaging for PCI treatment of coronary bifurcation lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Post-implant in-stent images obtained via 2D-/3D-OCT will be analyzed to assess the following:
1)Patterns of jailed strut links at side branch site
2)Guide wire recrossing positions into jailed strut
3)Ratio of area of jailed strut cell to area of side branch ostium after dilatation of the side branch
4)Frequency and quantitative evaluation of occurrence of incomplete stent apposition(ISA)
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To investigate coronaary bifurcation stenting with 2D, 3D OCT imaging.
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
1)Patient who has a side branch at the stented site and the luminal diameter of the side branch is more than 2mm visually.
2)Patiet with a de novo lesion in which stent will be implanted.
3)Patient who is 20 years of age or older when he/she provides the informed consent.
Key exclusion criteria
1)Patient who has a stent restenosis lesion in which stent will be implanted.
2)Patient with cardiogenic shock.
3)Patient with a chronic total occlusion lesion.
4)Patient with CKD of Cr more than 1.5mg/dl.
5)Patient who is considered not appropriate to undergo PCI.
6)Patient who has any other medical condition that in the opinion of the investigator will not be appropriate to participate in the investigation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junya Shite, Takayuki Okamura |
Organization
Osaka Saiseikai Nakatsu Hospital, Yamaguchi University Hospital
Division name
Cardiology
Zip code
Address
2-10-39, Shibata, Kita, Osaka
TEL
06-6372-0333
ricegoalflow@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junya Shite |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Cardiology
Zip code
Address
2-10-39, Shibata, Kita, Osaka
TEL
06-6372-0333
Homepage URL
ricegoalflow@yahoo.co.jp
Sponsor or person
Institute
3D-OCT investigators
Institute
Department
Personal name
Funding Source
Organization
3D-OCT Investigators
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
大阪府済生会中津病院（大阪府）、山口大学医学部附属病院（山口県）、山口県済生会山口総合病院（山口県）、済生会熊本病院（熊本県）、山口県立総合医療センター（山口県）、済生会横浜市東部病院（神奈川県）、福岡県済生会福岡総合病院（福岡県）、国立病院機構九州医療センター（福岡県）、祐愛会織田病院（佐賀県）、神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 04 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 03 | Day |
Last modified on
| 2021 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016219
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
