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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011061
Receipt No. 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

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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
Email 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
Email cto.e.registry@gmail.com

Sponsor
Institute Japanese CTO PCI Expert Registry investigators
Institute
Department

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
Email 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
URL(English) https://upload.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


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