UMIN-CTR Clinical Trial

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