UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061531 |
|---|---|
| Receipt number | R000070408 |
| Scientific Title | A Prospective, Single-Center, Single-Arm Interventional Study Evaluating Changes in Absolute Coronary Blood Flow and Coronary Microvascular Resistance Before and After Percutaneous Coronary Intervention Using Continuous Thermodilution in Patients with Chronic Coronary Syndrome |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/05/12 01:19:34 |
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Basic information
Public title
A study of coronary blood flow and small-vessel function before and after catheter-based coronary treatment in patients with chronic coronary syndrome
Acronym
CCS-FLOW Study
Scientific Title
A Prospective, Single-Center, Single-Arm Interventional Study Evaluating Changes in Absolute Coronary Blood Flow and Coronary Microvascular Resistance Before and After Percutaneous Coronary Intervention Using Continuous Thermodilution in Patients with Chronic Coronary Syndrome
Scientific Title:Acronym
CCS-FLOW Study
Region
| Japan |
Condition
Condition
Chronic Coronary Syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in absolute coronary blood flow and coronary microvascular resistance in the target vessel before and after percutaneous coronary intervention using continuous thermodilution in patients with chronic coronary syndrome scheduled to undergo PCI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in hyperemic absolute coronary blood flow Q in mL per min and hyperemic coronary microvascular resistance Rmu in Wood units in the target vessel from immediately before to immediately after PCI
Key secondary outcomes
1) Changes in coronary flow reserve (CFR), fractional flow reserve (FFR), and microvascular resistance reserve (MRR) in the target vessel from immediately before to immediately after PCI. 2) Inter-vessel heterogeneity of coronary microvascular resistance (Rmu) among the three major coronary arteries before PCI, including standard deviation, coefficient of variation, and max-min difference. 3) Absolute coronary blood flow, coronary microvascular resistance, and MRR in non-target vessels before PCI, and the prevalence of coronary microvascular dysfunction (CMD), defined as MRR less than 3.0. 4) Associations of changes in absolute coronary blood flow and coronary microvascular resistance with FFR, QCA findings, intracoronary imaging findings, and patient background factors. 5) Changes in patient-reported outcomes, including SAQ-7, PHQ-9, and GAD-7, from before PCI to approximately 1 month after PCI, and their associations with coronary physiological indices.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
During PCI, coronary physiological assessment will be performed using continuous thermodilution with the RayFlow catheter. Absolute coronary blood flow and coronary microvascular resistance will be measured in the target vessel immediately before PCI. When feasible in terms of procedure time, contrast volume, and hemodynamic stability, measurements will also be performed in the three major coronary arteries including non-target vessels before PCI. After PCI, only the target vessel will be measured again. The intervention will be performed once in the catheterization laboratory on the day of PCI. The additional procedure time is approximately 10 minutes when only the target vessel is measured before and after PCI, and approximately 20 minutes when three-vessel measurements before PCI and target-vessel measurement after PCI are performed. For each vessel, room-temperature saline will be infused at 10 mL/min for 60 seconds for resting measurement, followed by infusion at 20 mL/min for 60 seconds for hyperemic measurement.
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20 years or older. 2) Patients diagnosed with chronic coronary syndrome, including stable angina, exertional angina, or silent myocardial ischemia, who are scheduled to undergo percutaneous coronary intervention (PCI). 3) Patients who agree to undergo coronary blood flow assessment using continuous thermodilution with the RayFlow catheter during PCI. 4) Patients who are able to provide written informed consent for participation in this study.
Key exclusion criteria
1) Patients with acute coronary syndrome, including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina. 2) Patients with cardiogenic shock. 3) Patients with renal dysfunction, defined as eGFR less than 30 mL/min/1.73 m2. 4) Patients with allergy to contrast media. 5) Patients with contraindications to coronary angiography or PCI. 6) Patients with a target vessel diameter less than 2.0 mm in whom safe insertion or manipulation of the RayFlow catheter is considered difficult. 7) Patients with severe left ventricular dysfunction, defined as LVEF less than 30%. 8) Patients judged by the principal investigator to be unsuitable for the study. 9) Patients who do not provide consent for participation in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hoshino |
Organization
Institute of Science Tokyo Hospital
Division name
Department of cardiology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-5803-5231
hoshino.masahiro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hoshino |
Organization
Institute of Science Tokyo Hospital
Division name
Department of cardiology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5231
Homepage URL
hoshino.masahiro@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
Tel
03-5803-4547
rinri.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 12 | Day |
Last modified on
| 2026 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070408
