臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 22, 2023
Last modified on	Jan. 22, 2023
Trial ID	jRCT2052220154

Scientific Title	An Exploratory Multicenter, Open-Label Clinical Study to Evaluate the Safety and Efficacy of JFK-01 (Coronary Artery Absorbable Magnesium Alloy Scaffold) in Patients with Ischemic Heart Disease
Public Title	Exploratory Trial of JFK-01 (Coronary Artery Absorbable Magnesium Alloy Scaffold)

Contact for Scientific Queries	Name	Nakazawa Gaku
	Affiliation	Kindai University Hospital
	Address	377-2, Ohnohigashi, Osaka-Sayama City, Osaka Prefecture, Japan
	Telephone	+81-72-366-0221
	E-mail	gnakazawa@med.kindai.ac.jp
Contact for Public Queries	Name	Kawamura Akira
	Affiliation	Japan Medical Device Technology Co.,Ltd.
	Address	2020-3 Tahara, Mashiki Town, Kamimashiki-gun, Kumamoto Prefecture
	Telephone	+81-96-285-8278
	E-mail	a.kawamura@jmdt.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 12, 2023
Actual date of first enrollment
Target sample size		30
Study Type		Other
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. De Novo Coronary Lesions 2. One lesion or two lesions in one or two branches that are eligible for PCI 3. Lesions with visual diameter stenosis (AHA stenosis classification) greater than 75% and less than 100%. 4. Lesions with TIMI classification grade 1 or higher blood flow 5. Lesions with a visual control vessel diameter of 3 mm and lesion length of 18 mm or less
	Exclusion Criteria	1. highly calcified lesions for which angioplasty by balloon dilation (POBA, cutting balloon, or scoring balloon) appears to be infeasible 2. any of the following lesions or lesions for which adequate delivery of the device under study is not feasible (1) Severe bending of the target lesion or near site of the target lesion (2) severe tortuosity of the target lesion or near site of the target lesion (more than 2 bends of 45 degrees or more exist) 3. left main stem artery lesion 4. Bifurcation lesion in which the side branch is jailed by struts due to the implantation of the device in one of the following cases (1)lesions containing a side branch with a vessel diameter of 2 mm or greater (2) lesions requiring pre-dilation of the side branch (including kissing balloon) (3) lesions requiring a protective guidewire 5. lesion within 3 mm from the entrance of the right coronary artery 6. lesion within 3 mm of the origin of the left anterior descending branch of the coronary artery or the left circumflex branch of the coronary artery 7. bypass graft lesions or lesions distal to the bypass graft anastomosis 8. lesions with thrombus in the target vessel on pre-procedure angiography, IVUS, or OCT
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		ischemic heart disease
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Procedural success Angiographic evaluation OCT and IVUS evaluation
Secondary Outcome(s)

Primary Sponsor	Japan Medical Device Technology Co.,Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Clinical Trial Review Board of Kindai University Hospital
Address	377-2, Ohnohigashi, Osaka-Sayama City, Osaka Prefecture, Japan, Osaka
Telephone
E-Mail
Approval Status
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none