臨床研究等提出・公開システム

Date of registration	July. 17, 2026
Last modified on	July. 28, 2026
Trial ID	jRCT2032260325

Scientific Title	Clinical Trial of OMKK03 for De Novo Coronary Artery Lesions and Coronary Artery In-Stent Restenosis (Clinical Trial of OMKK03 for De Novo Coronary Artery Lesions and Coronary Artery In-Stent Restenosis)
Public Title	Clinical Trial of OMKK03 for De Novo Coronary Artery Lesions and Coronary Artery In-Stent Restenosis (Clinical Trial of OMKK03 for De Novo Coronary Artery Lesions and Coronary Artery In-Stent Restenosis)

Contact for Scientific Queries	Name	Yamamura Hidetoshi
	Affiliation	OrbusNeich Medical K.K.
	Address	Oakhouse201, 3-6-6 Uehara, Shibuya, Tokyo
	Telephone	+81-3-5738-5765
	E-mail	hyamamura@orbusneich.jp
Contact for Public Queries	Name	Yamamura Hidetoshi
	Affiliation	OrbusNeich Medical K.K.
	Address	Oakhouse201, 3-6-6 Uehara, Shibuya, Tokyo
	Telephone	+81-3-5738-5765
	E-mail	hyamamura@orbusneich.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		July. 17, 2026
Actual date of first enrollment		July. 22, 2026
Target sample size		282
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. The subject must be 18 years of age or older. 2. The subject must understand the requirements of this clinical trial and the trial procedures, and must provide written informed consent for participation in this clinical trial prior to undergoing any examinations or procedures related to the trial. 3. The subject must be indicated for percutaneous coronary intervention (PCI).
	Exclusion Criteria	1. Patients with acute myocardial infarction within 72 hours prior to the study procedure. 2. Patients with cardiogenic shock, unstable hemodynamics requiring inotropic agents or mechanical circulatory support, refractory ventricular arrhythmias, or progressive refractory angina. 3. Patients with severe left ventricular dysfunction with a left ventricular ejection fraction of less than 30%.
	Age Minimum	18age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		ischemic heart disease
Intervention(s)		PCI with OMKK03 or the control device
Primary Outcome(s)		Incidence rate of target lesion failure (TLF) assessed at 6 months after the trial procedure
Secondary Outcome(s)		Incidence rate of TLF assessed at 12 months after the trial procedure

Primary Sponsor	OrbusNeich Medical K.K.

Name of Certified Review Board	Tokushukai Group Institutional Review Board
Address	1-3-1, Kudan-minami, Chiyoda-ku, Tokyo, Japan, Tokyo, Tokyo
Telephone	+81-3-3263-4801
Approval Status	Approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	July. 28, 2026	(this page)	Changes
1	July. 17, 2026	Detail

List of change history