Safety and Feasibility of OCT-NIRAF Imaging in Coronary Atherosclerotic Lesions

JRCT ID: jRCTs032230541

Registered date:05/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic or acute coronary syndromes that indicated for PCI
• Date of first enrollment: 05/01/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): OCT-NIRAF multimodality imaging observations in coronary atherosclerotic lesions

Outcome(s)

• Primary Outcome: Incidence of device-oriented adverse events (within 30 days after initial PCI)

Secondary Outcome

(1) Incidence of device-oriented adverse events and device failure during the follow-up period
(2) NIRAF signals in normal coronary arteries and coronary atherosclerotic lesions
(3) Quality of OCT images on pre- and post-PCI OCT-NIRAF imaging acquired by the equipment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients diagnosed with chronic or acute coronary syndromes
(2) Patients who have coronary lesions indicated for PCI
(3) Patients aged 18 years or older at the time of informed consent
(4) Patients with written consent

Exclude criteria

(1) Patients with congestive heart failure (NYHA class IV)
(2) Patients with cardiogenic shock
(3) Patients with chronic total occluded lesions planned for PCI
(4) Patients deemed unable to undergo MMOCT imaging of the target vessel (e.g. vessel tortuosity)
(5) Patients with allergy to contrast media
(6) Patients with renal dysfunction (eGFR < 30 mL/min/1.73m2) (but not excluding dialysis patients)
(7) Patients with major bleeding (BARC type 3 or 5) within 14 days prior to PCI
(8) Patients with estimated life expectancy of 12 months or less
(9) Patients participating other clinical trials or interventional studies
(10) Patients under guardianship or conservatorship
(11) Patients with contraindications for antithrombotic therapy
(12) Patients with bacteremia or sepsis
(13) Patients with coagulation abnormalities
(14) Patients with vasodilator-resistant coronary artery spasm
(15) Patients with contraindications for investigational device
(16) Patients with possibility of pregnancy
(17) Patients deemed inappropriate by the investigator(s)

Related Information

• Primary Sponsor: Yonetsu Taishi
• Secondary Sponsor: Canon Medical Systems Corporation