臨床研究等提出・公開システム

Date of registration	June. 11, 2024
Last modified on	Mar. 28, 2025
Trial ID	jRCT1052240061

Scientific Title	Observational Study on Percutaneous Coronary Intervention for Chronic Total Occlusion Lesions
Public Title	Observational Study on Percutaneous Coronary Intervention for Chronic Total Occlusion Lesions

Contact for Scientific Queries	Name	katsuyuki hasegawa
	Affiliation	Higashi Takarazuka Satoh Hospital
	Address	2-1 Nagao-cho, Takarazuka-shi, Hyogo Prefecture
	Telephone	+81-797-88-2200
	E-mail	yrl03233@nifty.com
Contact for Public Queries	Name	katsuyuki hasegawa
	Affiliation	Higashi Takarazuka Satoh Hospital
	Address	2-1 Nagao-cho, Takarazuka-shi, Hyogo Prefecture
	Telephone	+81-797-88-2200
	E-mail	yrl03233@nifty.com

Recruitment status	Pending

Study Design
Anticipated date of first enrollment		June. 11, 2024
Target sample size		1000
Study Type		Observational



	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	(1) have a CTO in a coronary artery and plan to undergo PCI (2) be at least 18 years of age at the time of consent (3) have given written consent to participate in this study
	Exclusion Criteria	(1) Ineligible for PCI revascularization (2) Inadequately treated by the principal investigator
	Age Minimum	18age old over
	Age Maximum	No limit

Health Condition(s) or Problem(s) Studied		Chronic total occlusion of coronary arteries
Primary Outcome(s)		CTO-PCI procedure information and clinical outcomes of patients undergoing PCI are collected to build real-world data.

Primary Sponsor	ASAHI INTECC CO., LTD.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethics Committee of Higashi Takarazuka Satoh Ho spital
Address	2-1, Nagaocho, Takarazuka Shi, Hyogo Ken, 665-0 873, Japan, Hyogo
Approval Status	Approval
Date of approval	Nov. 29, 2023

Name of Certified Review Board	Ethics Committee of Hyogo Prefectural Harima-Hi meji General Medical Center
Address	3-264, Kamiyacho, Himeji Shi, Hyogo Ken, 670-08 36, Japan, Hyogo
Approval Status	Approval
Date of approval	Nov. 29, 2023

Name of Certified Review Board	21-1, Gobutori, Oyamacho, Toyohashi Shi, Aichi K en, 441-8530, Japan
Address	21-1, Gobutori, Oyamacho, Toyohashi Shi, Aichi K en, 441-8530, Japan, Hyogo
Approval Status	Approval
Date of approval	Nov. 29, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Mar. 28, 2025	(this page)	Changes
3	Sept. 30, 2024	Detail	Changes
2	Aug. 06, 2024	Detail	Changes
1	June. 11, 2024	Detail

List of change history