UMIN-ICDS Clinical Trial

Public title

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

Acronym

Dual-Imaging CALC Registry

Scientific Title

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

Scientific Title:Acronym

Dual-Imaging CALC Registry

Region

Japan

Condition

Coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to verify the compatibility of a new intravascular ultrasound (IVUS) marker with an optical coherence tomography (OCT) calcium score of 3 or more points, which is used in Japan to determine the clinical indication for intravascular lithotripsy (IVL) targeting calcified lesions during percutaneous coronary intervention (PCI), a treatment for coronary artery disease.

Basic objectives2

Others

Basic objectives -Others

The compatibility of IVUS-derived maximum calcium angle > 225 degrees with an OCT calcium score of 3 or more points

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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

Target sample size

200

Name of lead principal investigator

1st name	Kiyoshi
Middle name
Last name	Hibi

Organization

Yokohama City University Hospital
Yokohama City University Medical Center

Division name

Department of Cardiology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa-ken

TEL

045-787-2800

Email

hibikiyo@yokohama-cu.ac.jp

Name of contact person

1st name	Noriko
Middle name
Last name	Kawarada

Organization

Micron, Inc.

Division name

Research office of Dual-Imaging CALC Registry

Zip code

108-0075

Address

Shinagawa TS Building 5F, 2-13-40 Konan, Minato-ku, Tokyo

TEL

03-6631-3691

Homepage URL

Email

dual-imaging_calc@micron-kobe.com

Institute

Yokohama City University

Institute

Department

Personal name

Organization

Shockwave Medical Inc.

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yokohama City University, Ethics Committee for Medical Research Involving Human Subjects

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa-ken

Tel

045-370-7627

Email

rinri@yokohama-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜市立大学附属病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
九州大学病院（福岡県）
東京ベイ・浦安市川医療センター（千葉県）
沖縄徳洲会 湘南鎌倉総合病院（神奈川県）
横須賀共済病院（神奈川県）
東邦大学医療センター大橋病院（東京都）
横浜栄共済病院（神奈川県）
横浜南共済病院（神奈川県）
昭和医科大学病院（東京都）
横須賀市立総合医療センター（神奈川県）
北播磨総合医療センター（兵庫県）
榊原記念病院（東京都）
東宝塚さとう病院（兵庫県）
岩手医科大学附属病院（岩手県）
国立循環器病研究センター（大阪府）
福岡和白病院（福岡県）
新古賀病院（福岡県）
北里大学病院（神奈川県）

Date of disclosure of the study information

2026

Year

06

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2026

Year

03

Month

27

Day

Date of IRB

2026

Year

06

Month

08

Day

Anticipated trial start date

2026

Year

06

Month

09

Day

Last follow-up date

2028

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2029

Year

12

Month

31

Day

Other related information

[Baseline/Screening]
Patient basic information
Diagnosis of ischemic heart disease
Presence and details of coronary risk factors
Past medical history
Left ventricular ejection fraction
12-lead electrocardiogram
Clinical laboratory values: White blood cell count, hemoglobin, platelet count, creatinine, eGFR, blood glucose, HbA1c, triglycerides, LDL-C, HDL-C, high-sensitivity CRP, BNP/NT-pro BNP
Cardiac enzymes: CK, CK-MB, troponin T or I
Cardiac CT
Medication information

[Registration/PCI Procedure (Day 0)]
Procedure and Device Information
PCI Information
Lesion Information
Calcification Assessment: Coronary angiography, OCT/OFDI, and IVUS assessment
Device Information
Other: Procedure time, fluoroscopy time, contrast agent amount
Pre-operative, intra-operative, and post-operative coronary angiography assessment
Pre-operative, intra-operative, and post-operative OCT/OFDI and IVUS assessment
Presence and details of complications from catheter treatment
Presence and details of circulatory support use

[The day after the procedure (12-24 hours post-procedure) or at discharge]
Clinical laboratory values: white blood cell count, hemoglobin, platelet count, creatinine, eGFR
Cardiac enzymes: CK, CK-MB, troponin T or I
12-lead electrocardiogram
Event evaluation: all-cause mortality, cardiac death, vascular death, non-cardiovascular death, myocardial infarction (perioperative myocardial infarction, spontaneous myocardial infarction), stent thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR)

[Follow-up at 30 days and 12 months post-procedure]
Medication information
Event evaluation: all-cause mortality, cardiac death, vascular death, non-cardiovascular death, myocardial infarction, stent thrombosis, TLR, TVR
Angiography and OCT/OFDI or IVUS (if performed)

Registered date

2026

Year

06

Month

09

Day

Last modified on

2026

Year

06

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069825