UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044788 |
|---|---|
| Receipt number | R000051154 |
| Scientific Title | Prediction of successful guidewire crossing of below-the-knee chronic total occlusions |
| Date of disclosure of the study information | 2021/07/07 |
| Last modified on | 2024/01/08 09:11:20 |
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Basic information
Public title
Prediction of successful guidewire crossing of below-the-knee chronic total occlusions
Acronym
J-BTK CTO validation study
Scientific Title
Prediction of successful guidewire crossing of below-the-knee chronic total occlusions
Scientific Title:Acronym
J-BTK CTO validation study
Region
| Japan |
Condition
Condition
Peripheral Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the scoring system that could adequately predict successful overall guidewire crossing of BTK CTOs in angiographic evaluation. Five variables were selected. No outflow of the target vessel, CTO length more than 200mm,RVD less than 2mm,Calcification at the proximal entry point, and Blunt type at entry point and assigned points with the best score model adopted as the Japanese BTK CTO score.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between success rate of guidewire crossing and the J-BTK CTO score
Key secondary outcomes
Procedural complications
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subject has symptomatic peripheral arterial disease of Rutherford category 4-6.
2. Subject has a chronic total occlusion located in the anterior tibial, posterior tibial, peroneal artery, and tibioperoneal trunk areas.
Key exclusion criteria
1.Subjects who rejected to participate this study through Opt-out method applied by a poster.
2.Acute occlusive intraluminal thrombosis of the proposed lesion site.
3.In-stent restenosis or in-stent occlusion of the proposed lesion site.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Michinao |
| Middle name | |
| Last name | Tan |
Organization
Tokeidai Memorial Hospital
Division name
Cardiovascular center
Zip code
060-0031
Address
2-3 North-1, East1, Chuo-Ku Sapporo, Hokkaido, Japan
TEL
011-251-1221
t.michinao@gmail.com
Public contact
Name of contact person
| 1st name | Michinao |
| Middle name | |
| Last name | Tan |
Organization
Tokeidai Memorial Hospital
Division name
Cardiovascular center
Zip code
060-0031
Address
2-3 North-1, East1, Chuo-Ku Sapporo, Hokkaido, Japan
TEL
011-251-1221
Homepage URL
t.michinao@gmail.com
Sponsor or person
Institute
Tokeidai Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokeidai Memorial Hospital
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
Tokeidai Memorial Hospital
Address
2-3 North-1, East1, Chuo-Ku Sapporo, Hokkaido, Japan
Tel
011-251-1221
t.michinao@gmail.com
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
| 2021 | Year | 07 | Month | 07 | 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
751
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
All candidates have been enrolled. Input data is currently being aggregated at each hospital.
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
From the medical records of the research participating facilities, patient background information such as age , gender of the study subject, disease name including comorbidities, treatment status, physical findings (height, weight, blood pressure, etc.), blood test, physiological imaging test (ankle-brachial pressure index, skin perfusion pressure, ultrasonography, angiography, etc.), and procedural details will be used. Using the extracted data, we will validate the scoring system that could adequately predict successful overall guidewire crossing of BTK CTOs.
Management information
Registered date
| 2021 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051154
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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