UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study for Plasma Wire System (FIM-2)
Title of the study (Brief title)	FIM-2
Region	Japan

Condition
Condition	Chronic total occlusion
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To achieve CTO penetration of antegrade wire more easily and more effectively and to confirm the safety, by penetrating into CTO inlet and true lumen or making re-entry using new RF generator with appropriate circuit, two kinds of PlasmaWire and penetration catheter W-OTW which has double OTW lumen. Moreover, to confirm the safety of PlasmaWire System in case of switching from antegrade approach to retrograde approach.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy of the device, antegrade procedure success and patient success.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
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	-
Key exclusion criteria	-
Target sample size	10

Research contact person
Name of lead principal investigator	Kenya Nasu
Organization	Toyohashi Heart Center
Division name	Cardiovascular Medicine
Address	21-1 Gobudori, Oyama-Cho, Toyohashi, Aichi 441-8530 Japan
TEL	0532-37-3377
Email	nasu@heart-center.or.jp

Public contact
Name of contact person	Kenya Nasu
Organization	Toyohashi Heart Center
Division name	Cardiovascular Medicine
Address	21-1 Gobudori, Oyama-Cho, Toyohashi, Aichi 441-8530 Japan
TEL	0532-37-3377
Homepage URL
Email	nasu@heart-center.or.jp

Sponsor
Institute	Toyohashi Heart Center Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Toyohashi Heart Center Cardiovascular Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 06 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 20 Day
Anticipated trial start date	2017 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 23 Day
Last modified on	2017 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031952