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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032230541

Enrollment

Registered

2024-01-05

Start date

2024-05-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic or acute coronary syndromes that indicated for PCI

Interventions

OCT-NIRAF multimodality imaging observations in coronary atherosclerotic lesions

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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)

Design outcomes

Primary

Measure	Time frame
Incidence of device-oriented adverse events (within 30 days after initial PCI)	—

Secondary

Measure	Time frame
(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	—

Contacts

Public ContactTomoyo Sugiyama

Institute of Science Tokyo Hospital

mmoct-fim@ml.tmd.ac.jp+81-3-5803-5231

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026