UMIN-ICDS Clinical Trial

Public title

A prospective IVI validation of coronary stent optimization after CT-guided PCI

Acronym

The ACTION-CT PCI Study

Scientific Title

A prospective IVI validation of coronary stent optimization after CT-guided PCI

Scientific Title:Acronym

A prospective IVI validation of coronary stent optimization after CT-guided PCI

Region

Japan

Condition

Stable angina pectoris

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to prospectively evaluate the frequency of intravascular imaging findings that may warrant additional stent optimization following CT-guided PCI. This study is designed as a mechanistic investigation to objectively assess post-PCI findings after CT-guided PCI, rather than to compare clinical outcomes or evaluate treatment efficacy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Primary Outcome

The proportion of patients with at least one intravascular imaging finding that may warrant additional stent optimization, as identified by post hoc analysis following CT-guided PCI.

IVUS Criteria for Findings Potentially Requiring Additional Optimization

Stent underexpansion: Minimum stent area (MSA) of 5.0 mm2 or less, or less than 90% of the distal reference lumen area.

Significant residual plaque burden: Plaque burden of 50% or greater within 5 mm proximal or distal to the stent edge.

Significant stent edge dissection: Dissection involving the media or measuring 3 mm or greater in length.

OCT Criteria for Findings Potentially Requiring Additional Optimization

Suboptimal stent expansion: Failure to meet all of the following criteria:

MSA of at least 80% of the mean reference lumen area.

MSA of at least 100% of the distal reference lumen area.

MSA greater than 4.5 mm2.

Suboptimal stent apposition: Maximum malapposition distance of 400 um or greater.

Major stent edge dissection: Presence of any of the following:

Dissection flap angle of 60 degrees or greater.

Dissection length of 3 mm or greater.

Deep vessel injury involving the media or deeper vessel layers.

These criteria are based on previous studies and established clinical considerations and do not represent study-specific criteria mandating additional intervention.

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.Patients who have undergone preprocedural coronary computed tomography angiography (CCTA).

2.Patients with clinically suspected myocardial ischemia who are scheduled for elective percutaneous coronary intervention (PCI). The indication for revascularization is determined based on coronary angiography, invasive FFR, FFRCT, myocardial perfusion imaging, or exercise electrocardiography, in accordance with the Japanese Circulation Society (JCS) guidelines.

3.Patients with non-culprit lesions following acute coronary syndrome (ACS) are also eligible.

4.Patients in whom intravascular ultrasound (IVUS) or optical coherence tomography (OCT) assessment is feasible during PCI.

5.Patients who have provided written informed consent to participate in the study.

Key exclusion criteria

1.Patients requiring emergency PCI.

2.Patients with in-stent restenosis.

3.Patients with left main coronary artery disease, chronic total occlusion, complex bifurcation lesions, or severely calcified lesions.

4.Patients with three-vessel disease for whom surgical revascularization is considered more appropriate.

5.Patients unable to continue antiplatelet or anticoagulant therapy.

6.Patients considered unsuitable for study participation due to active malignancy or other conditions.

7.Patients in whom preprocedural CCTA analysis is not feasible due to poor image quality or other technical limitations.

8.Patients with severe renal dysfunction for whom contrast administration is considered clinically inappropriate (e.g., eGFR less than 30 mL/min/1.73 m2). Patients receiving maintenance dialysis are eligible.

9.Patients in whom CCTA or PCI cannot be safely performed due to contrast media allergy or other contraindications.

10.Patients with severe systemic conditions that make study participation inappropriate, including severe heart failure, active infection, or diseases associated with a limited life expectancy.

11.Patients who are unlikely to comply with the study procedures, including those for whom continued follow-up after informed consent is difficult.

12.Patients considered unsuitable for study participation for any other reason, as determined by the principal investigator or treating physician.

Target sample size

100

Name of lead principal investigator

1st name	Tajima
Middle name
Last name	Atomu

Organization

Aichi medical university hospital

Division name

Department of Cardiology

Zip code

440-0814

Address

1-1 Yazakokarimata, Nagakute, Aichi,Japan

TEL

09091967254

Email

atomu.tajima0118@outlook.jp

Name of contact person

1st name	Atomu
Middle name
Last name	Tajima

Organization

Aichi Medical University Hospital

Division name

Department of Cardiology

Zip code

480-1195

Address

1-1 Yazakokarimata, Nagakute, Aichi,Japan

TEL

0561-62-3311

Homepage URL

Email

atomu.tajima0118@outlook.jp

Institute

Aichi Medical University

Institute

Department

Personal name

Organization

Aichi Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Aichi Medical University School of Medicine

Address

1-1 Yazakokarimata, Nagakute, Aichi,Japan

Tel

0561-62-3311

Email

amu_ethics@aichi-med-u.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

Date of disclosure of the study information

2026

Year

11

Month

05

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

16

Day

Date of IRB

2026

Year

03

Month

16

Day

Anticipated trial start date

2026

Year

04

Month

24

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is an observational study evaluating stent implantation results using intravascular imaging (IVUS/OCT) following CT-guided PCI. Intravascular imaging findings, including stent expansion, malapposition, edge dissection, and residual plaque, will be assessed to determine the frequency of findings warranting consideration of additional optimization. The decision to perform additional treatment will be left to the operator's discretion.

Registered date

2026

Year

11

Month

05

Day

Last modified on

2026

Year

11

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072696