臨床研究等提出・公開システム

Date of registration	Jan. 17, 2023
Last modified on	Jan. 26, 2024
Trial ID	jRCT1010220034

Scientific Title	Basic research on vessel axis deviation of coronary arteries
Public Title	Basic research on vessel axis deviation of coronary arteries

Contact for Scientific Queries	Name	Matsuno Shunsuke
	Affiliation	The Cardiovascular Institute
	Address	3-2-19, Nishiazabu,Minato-ku,Toky-to,Japan
	Telephone	+81-3-3408-2151
	E-mail	matsuno@cvi.or.jp
Contact for Public Queries	Name	Ueda Kanoko
	Affiliation	Asahiintecc co.,LTD
	Address	3-100 Akatsuki-cho,Seto-shi,Aichi
	Telephone	+81-561-41-8330
	E-mail	kanoko.ueda@asahi-intecc.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 17, 2023
Actual date of first enrollment		Jan. 27, 2023
Target sample size		100
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Undergo PCI (2) Ages: 18 years and older (3) Willing and able to provide written informed concent
	Exclusion Criteria	May have difficulty in maintaining and controlling breathing and body movements according to the physician's instructions.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		coronary artery disease
Intervention(s)		Fluoroscopic imaging after standard PCI
Primary Outcome(s)		Identification of factors influencing the deviation of the vessel axis

Primary Sponsor	Asahi Intecc co.,LTD.

Secondary Sponsor	Not applicable

Secondary Sponsor

Name of Certified Review Board	Ethics Committee of Sapporo Heart Center Sapporo Cardiovascular Clinic
Address	16-8-1, Kita49-johigashi, Sapporo Shi Higashi Ku, Hokkaido, Hokkaido
Approval Status	Approval
Date of approval	Dec. 17, 2022

Name of Certified Review Board	Ethics Committee of Mie Heart Center
Address	2227-1, Oyodo, Taki Gun Meiwa Cho, Mie Ken, 515-0302, Japan, Hokkaido
Approval Status	Approval
Date of approval	Dec. 17, 2022

Name of Certified Review Board	Ethics Committee of the Cardiovascular Institute
Address	3-2-19, Nishiazabu,Minato-ku,Toky-to,Japan, Hokkaido
Approval Status	Approval
Date of approval	Dec. 17, 2022

Name of Certified Review Board	Ethics Committee of Saiseikai Utsunomiya Hospital
Address	911-1, Takebayashimachi, Utsunomiya Shi, Tochigi Ken, 321-0974, Japan, Hokkaido
Approval Status	Approval
Date of approval	Dec. 17, 2022

Name of Certified Review Board	Ethics Committee of Toyohashi Heart Center
Address	21-1, Gobutori, Oyamacho, Toyohashi Shi, Aichi Ken, 441-8530, Japan, Hokkaido
Approval Status	Approval
Date of approval	Dec. 17, 2022

Name of Certified Review Board	Ethics Committee of Kusatsu Heart Center
Address	407-1, Komaizawacho, Kusatsu Shi, Shiga Ken, 525-0014, Japan, Hokkaido
Approval Status	Approval
Date of approval	Dec. 17, 2022

Name of Certified Review Board	Ethics Committee of Hyogo Prefectural Harima-Himeji General Medical Center
Address	3-264, Kamiyacho, Himeji Shi, Hyogo Ken, 670-0836, Japan, Hokkaido
Approval Status	Approval
Date of approval	Dec. 17, 2022

Name of Certified Review Board	Ethics Committee of Higashi Takarazuka Satoh Hospital
Address	2-1, Nagaocho, Takarazuka Shi, Hyogo Ken, 665-0873, Japan, Hokkaido
Approval Status	Approval
Date of approval	Dec. 17, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Jan. 26, 2024	(this page)	Changes
3	Aug. 23, 2023	Detail	Changes
2	April. 29, 2023	Detail	Changes
1	Jan. 17, 2023	Detail

List of change history