Dual-Imaging CALC Registry (Dual Imaging Modality Assessment of Coronary Calcified Lesion Scoring Using IVUS and OCT)

Dual Imaging Modality Assessment of Coronary Calcified Lesion Scoring Using IVUS and OCT - Dual-Imaging CALC Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061846

Enrollment

200

Registered

2026-06-09

Start date

2026-06-09

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

Coronary artery disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age 18 years or older 2) The patient or legally authorized surrogate decision-maker has signed an informed consent form for participation in this study prior to the procedures outlined in this study. 3) Has coronary artery disease requiring PCI. 4) Stent placement is planned during PCI. 5) Moderate or severe calcified lesions are observed on angiography. 6) Evaluation by OCT/OFDI and IVUS is possible.

Exclusion criteria

Exclusion criteria: 1) Patients with comorbidities or symptoms that may prevent follow-up visits or protocol compliance 2) Patients participating in or potentially participating in other studies who have not met the primary endpoint using other research products (pharmaceuticals, biological agents, or medical devices) or whose use may affect this study 3) Patients who have already enrolled one lesion in this study 4) Patients who cannot use anticoagulant/antiplatelet therapy recommended by the Japanese Circulation Society guidelines 5) Patients with contrast agent allergies who cannot use steroids 6) Patients with cardiogenic shock 7) Patients with decompensated acute heart failure 8) Patients with renal failure not undergoing dialysis (serum creatinine > 2.0 mg/dL) 9) Pregnant women or women planning to become pregnant 10) Patients whose life expectancy is expected to be less than one year. 11) Patients deemed ineligible for this study by a physician 12) Culprit lesion in ST-segment elevation acute myocardial infarction 13) Lesion at the left main coronary artery ostium or right coronary artery ostium 14) Bypass graft lesion 15) In-stent restenosis lesion 16) Chronic total occlusion lesion

Design outcomes

Primary

Measure	Time frame
Positive predictive value of IVUS-derived maximum calcium angle > 225 degrees to predict OCT calcium score of 3 or more points	—

Countries

Japan

Contacts

Public ContactNoriko Kawarada

Micron, Inc. Research office of Dual-Imaging CALC Registry

dual-imaging_calc@micron-kobe.com03-6631-3691

Outcome results