UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011061 |
|---|---|
| Receipt number | R000012914 |
| Scientific Title | Patient Registry of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) by Japanese experts |
| Date of disclosure of the study information | 2013/06/30 |
| Last modified on | 2019/07/02 10:43:07 |
* 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
Patient Registry of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) by Japanese experts
Acronym
Japanese CTO PCI Expert Registry
Scientific Title
Patient Registry of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) by Japanese experts
Scientific Title:Acronym
Japanese CTO PCI Expert Registry
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Chronic total occlusion
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a consensus of treatment strategy of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) through patient registry of PCI for CTO performed by Japanese certified operators
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Early results: successful revascularization without any major adverse cardiocerebral events (MACCE).
Late results: MACCE during the 5-year follow-up
Key secondary outcomes
Early results:
1) Death in hospital, MACCE
2) Renal dysfunction (contrast-induced nephropathy), radiation dermatitis
3) Manipulation time, exposure dose,
X-ray fluoroscoping time, dose of contrast media
Late results: Revascularization (PCI/CAGB)
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
Patients eligible for PCI
Patients who underwent PCI for CTO
lesions that contain the following:
1. Thrombolysis in myocardial infarction trial (TIMI) 0
2. The occulsive period more than 3 months or unknown
3. The main coronary arteries (segment1-3, 5-8, 11,13) , branches that have large perfusion area (seg 4PL, 9/10, 12), and graft
Key exclusion criteria
Patients ineligible for PCI judged in clinical practice
Target sample size
19000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital
Division name
Department of Cardiology
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
086-422-0210
ht7307@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Oka |
Organization
Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital
Division name
Secretariat of the Japanese CTO PCI Expert Registry
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
086-422-0210
Homepage URL
cto.e.registry@gmail.com
Sponsor or person
Institute
Japanese CTO PCI Expert Registry investigators
Institute
Department
Personal name
Funding Source
Organization
Japanese board of Chronic Total Occlusion Interventional specialist
(General Incorporated Association)
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
Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
Tel
086-422-0210
kenkyu@kchnet.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01889459
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2013 | Year | 06 | Month | 28 | Day |
Last modified on
| 2019 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012914
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
