Coronary Artery DiseaseNCT07176585
A Prospective, Single-site, Single-group Value Study on the Diagnosis of Functional Myocardial Ischemia Based on IVUS Plaque Characteristics
An observational study of Coronary Artery Disease, run by Insight Lifetech Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the accuracy of IVUS-calculated percent atheroma volume (PAV) for diagnosing functional myocardial ischemia, using FFR as the gold standard. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2025to 4 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multivessel coronary artery disease.
Who may be able to join
- Study participants must be at least 18 years of age and younger than 80 years of age, regardless of gender;
- Stable coronary artery disease, unstable angina, or acute myocardial infarction (AMI ≥ 7 days);
- Coronary angiography showed primary lesions with a visual stenosis of 30% to 90% in at least two coronary arteries ≥ 2.5 mm in diameter;
- Willing to participate in the study and able to understand, read, and sign the informed consent form.
Who cannot join
- STEMI as clinical presentation within 7 days;
- Chronic Total Occlusion (CTO) as target vessel;
- Significant contraindication to adenosine administration (e.g., atrioventricular block, severe asthma, etc.);
- Study participants are currently participating in other drug or device clinical studies and have not achieved the study endpoints;
- Pregnant or nursing;
- Other situations considered by the investigator as unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the accuracy of IVUS-calculated percent atheroma volume (PAV) for diagnosing functional myocardial ischemia, using FFR as the gold standard.
Read the detailed description
This prospective, single-site, single-group target-value study aims to investigate the accuracy of intravascular ultrasound (IVUS)-based plaque characteristics in diagnosing functional myocardial ischemia, using coronary fractional flow reserve (FFR) as the gold standard.
- Conditions
- Coronary Artery Disease
- Keywords
- IVUS, FFR, PCI, CAD
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy of IVUS-derived percent atheroma volume (PAV) for identifying physiologically significant coronary stenoses
The prespecified primary endpoint was the diagnostic accuracy of IVUS-derived percent atheroma volume (PAV) for identifying physiologically significant coronary stenoses, defined as fractional flow reserve (FFR) ≤0.80, using a PAV threshold of ≥39.0%.
Measured: Intraoperative period（After coronary angiography, before the potential PCI）
Secondary outcomes (8)
The diagnostic sensitivity and specificity of IVUS-derived percent atheroma volume (PAV) for identifying physiologically significant coronary stenoses
The key secondary endpoints were the diagnostic sensitivity and specificity of IVUS-derived percent atheroma volume (PAV) for identifying physiologically significant coronary stenoses, defined as fractional flow reserve (FFR) ≤0.80, using a PAV threshold of ≥39.0%.
Measured: Intraoperative period（After coronary angiography, before the potential PCI）
The positive predictive value, negative predictive value, Receiver Operating Characteristic Curve (ROC) and Area Under the Curve (AUC) of IVUS-derived PAV for identifying physiologically significant coronary stenoses
Using blood vessels as the research unit and FFR values measured by pressure microcatheters as reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the positive predictive value, negative predictive value, Receiver Operating Characteristic Curve (ROC), and Area Under the Curve (AUC) of IVUS-derived PAV for identifying physiologically significant coronary stenoses (PAV ≥ 39.0% is positive, PAV < 39.0% is negative).
Measured: Intraoperative period（After coronary angiography, before the potential PCI）
Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Total Atheroma Volume (TAV) calculated from IVUS images on the diagnosis of functional myocardial ischemia
Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Total Atheroma Volume (TAV) calculated from IVUS images on the diagnosis of functional myocardial ischemia.
Measured: Intraoperative period（After coronary angiography, before the potential PCI）
Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Minimum Lumen Area (MLA) calculated from IVUS images on the diagnosis of functional myocardial ischemia
Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Minimum Lumen Area (MLA) calculated from IVUS images on the diagnosis of functional myocardial ischemia.
Measured: Intraoperative period（After coronary angiography, before the potential PCI）
Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Plaque Burden (PB) calculated from IVUS images on the diagnosis of functional myocardial ischemia
Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Plaque Burden (PB) calculated from IVUS images on the diagnosis of functional myocardial ischemia.
Measured: Intraoperative period（After coronary angiography, before the potential PCI）
Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Diameter Stenosis (DS%) calculated by Quantitative Coronary Angiography (QCA) on diagnosing functional myocardial ischemia
Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Diameter Stenosis degree (DS%) calculated by Quantitative Coronary Angiography (QCA) on diagnosing functional myocardial ischemia.
Measured: Intraoperative period（After coronary angiography, before the potential PCI）
Correlation between PAV, TAV, MLA, PB, DS% and FFR in pairwise comparisons
Using blood vessels as the research unit, conducting Passing Bablok regression analysis and Pearson linear correlation analysis on Percent Atheroma Volume (PAV), Total Atheroma Volume (TAV), Minimum Lumen Area (MLA), Plaque Burden (PB), Diameter Stenosis degree (DS%) and Fractional Flow Reserve (FFR).
Measured: Intraoperative period（After coronary angiography, before the potential PCI）
Correlation between PAV gradient calculated from IVUS images and FFR Pullback Pressure Gradient (PPG)
Using blood vessels as the research unit, PAV was calculated every 1mm along the vascular direction based on IVUS images, and FFR Pullback Pressure Gradient (PPG) distribution was calculated based on FFR pullback. The correlation between PAV gradient distribution along the vascular direction and FFR PPG was evaluated.
Measured: Intraoperative period（After coronary angiography, before the potential PCI）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start23 Sep 2025
- Primary completion4 Jan 2026
- Study completion4 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insight Lifetech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176585
- Sponsor's protocol ID
- CIP-0201
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-site, Single-group Value Study on the Diagnosis of Functional Myocardial Ischemia Based on IVUS Plaque Characteristics
- ClinicalTrials.gov ID
- NCT07176585
- Acronym / sponsor ID
- CIP-0201
- Conditions
- Coronary Artery Disease
- Keywords
- IVUS, FFR, PCI, CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Insight Lifetech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- 4 Jan 2026 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the accuracy of IVUS-calculated percent atheroma volume (PAV) for diagnosing functional myocardial ischemia, using FFR as the gold standard.
Detailed description
This prospective, single-site, single-group target-value study aims to investigate the accuracy of intravascular ultrasound (IVUS)-based plaque characteristics in diagnosing functional myocardial ischemia, using coronary fractional flow reserve (FFR) as the gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multivessel coronary artery disease.
Key inclusion criteria (4 listed)
- Study participants must be at least 18 years of age and younger than 80 years of age, regardless of gender;
- Stable coronary artery disease, unstable angina, or acute myocardial infarction (AMI ≥ 7 days);
- Coronary angiography showed primary lesions with a visual stenosis of 30% to 90% in at least two coronary arteries ≥ 2.5 mm in diameter;
- Willing to participate in the study and able to understand, read, and sign the informed consent form.
Key exclusion criteria (6 listed)
- STEMI as clinical presentation within 7 days;
- Chronic Total Occlusion (CTO) as target vessel;
- Significant contraindication to adenosine administration (e.g., atrioventricular block, severe asthma, etc.);
- Study participants are currently participating in other drug or device clinical studies and have not achieved the study endpoints;
- Pregnant or nursing;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diagnostic accuracy of IVUS-derived percent atheroma volume (PAV) for identifying physiologically significant coronary stenoses
Time frame: Intraoperative period（After coronary angiography, before the potential PCI）
The prespecified primary endpoint was the diagnostic accuracy of IVUS-derived percent atheroma volume (PAV) for identifying physiologically significant coronary stenoses, defined as fractional flow reserve (FFR) ≤0.80, using a PAV threshold of ≥39.0%.
8 secondary outcomes
The diagnostic sensitivity and specificity of IVUS-derived percent atheroma volume (PAV) for identifying physiologically significant coronary stenoses
Time frame: Intraoperative period（After coronary angiography, before the potential PCI）
The positive predictive value, negative predictive value, Receiver Operating Characteristic Curve (ROC) and Area Under the Curve (AUC) of IVUS-derived PAV for identifying physiologically significant coronary stenoses
Time frame: Intraoperative period（After coronary angiography, before the potential PCI）
Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Total Atheroma Volume (TAV) calculated from IVUS images on the diagnosis of functional myocardial ischemia
Time frame: Intraoperative period（After coronary angiography, before the potential PCI）
Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Minimum Lumen Area (MLA) calculated from IVUS images on the diagnosis of functional myocardial ischemia
Time frame: Intraoperative period（After coronary angiography, before the potential PCI）
Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Plaque Burden (PB) calculated from IVUS images on the diagnosis of functional myocardial ischemia
Time frame: Intraoperative period（After coronary angiography, before the potential PCI）
Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Diameter Stenosis (DS%) calculated by Quantitative Coronary Angiography (QCA) on diagnosing functional myocardial ischemia
Time frame: Intraoperative period（After coronary angiography, before the potential PCI）
Correlation between PAV, TAV, MLA, PB, DS% and FFR in pairwise comparisons
Time frame: Intraoperative period（After coronary angiography, before the potential PCI）
Correlation between PAV gradient calculated from IVUS images and FFR Pullback Pressure Gradient (PPG)
Time frame: Intraoperative period（After coronary angiography, before the potential PCI）
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Insight Lifetech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic accuracy of IVUS-derived percent atheroma volume (PAV) for identifying physiologically significant coronary stenoses (time frame: Intraoperative period（After coronary angiography, before the potential PCI）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.