UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017554 |
|---|---|
| Receipt number | R000020345 |
| Scientific Title | Evaluation of new image processing software that supports percutaneous coronary intervention |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2015/05/13 23:48:58 |
* 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
Evaluation of new image processing software that supports percutaneous coronary intervention
Acronym
Evaluation of new image processing software that supports percutaneous coronary intervention
Scientific Title
Evaluation of new image processing software that supports percutaneous coronary intervention
Scientific Title:Acronym
Evaluation of new image processing software that supports percutaneous coronary intervention
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the potential clinical value of the image processing software that supports percutaneous coronary intervention
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Accuracy of Co-retgistration between angiographic images and IVUS images
Key secondary outcomes
radiation dose
1) radiation dose of fluoroscopy during pullback of IVUS
2) total radiation dose in each case
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
1) patients who undertake percutaneous coronary intervention
2) patients with elective cases
3) patients who are over 20 years old when informed consent are collected
4) patients from whom informed consent are collected with adequate understanding of the research
Key exclusion criteria
1) patients with 3 vessel disease
2) patients with left main trunk disease
3) patients with total occlusion disease
4) patients who should not undertake IVUS
5) women who are or are likely to be pregnant or nursing
6) patients whom primary investigators or sub investigators decide to exclude because of inadequacies for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Ando |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL
+81-3-3815-5411
jando-kkr@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Ando |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL
+81-3-3815-5411
Homepage URL
jando-kkr@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Siemens Japan K.K.
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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 14 | 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
| 2012 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of accuracy of Co-retgistration between angiographic images and IVUS images
Management information
Registered date
| 2015 | Year | 05 | Month | 13 | Day |
Last modified on
| 2015 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020345
