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Coronary Artery DiseaseNCT05807841

Clinical Impact of Intravascular Ultrasound-Based Artificial Intelligence Technologies (INNOVATE-PCI)

An observational study of Coronary Artery Disease, run by Asan Medical Center at 16 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a prospective, multicenter study in the real practice to validate the diagnostic performances and clinical impact of coronary angiography \& intravascular ultrasound (IVUS)-based models developed by machine learning (ML). Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
percutaneous coronary intervention
Type of treatment
Surgery or procedure
How many people
3,000 participants
Where
16 sitesSouth Korea
Study dates
20 Feb 2020to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Between February 2020 and June 2027, a total of 3,000 patients who performe coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea.

Who may be able to join

  • Age 19 years or older
  • Symptomatic angina patients with objective myocardial ischemia
  • Patients with at least one major epicardial coronary artery that requires stent implantation
  • Subject who signs with informed consent form
  • Patient exclusion Criteria:
  • ST-segment elevation MI at admission
Show all 23Show fewer
  • Patients who underwent coronary artery bypass surgery or heart transplantation
  • Left ventricular ejection fraction <30%
  • Cardiogenic shock
  • Patients whose life expectancy <2 years
  • Woman who are breastfeeding, pregnant or planning to become pregnant during study
  • Patients in whom anti-platelets or heparin is contraindicated
  • Lesion exclusion Criteria:
  • Left main culprit lesion (angiographic diameter stenosis >50%)
  • Thrombus-containing lesion
  • In-stent restenosis
  • Side branch lesion
  • Chronic total occlusion
  • Small vessel with reference diameter <2.5mm
  • Coronary spasm despite administration of nitrate
  • Inability for imaging catheter to pass through tight stenosis, calcification, angulations
  • Poor image quality
  • Angiographically visible collateral vessels

Who cannot join

None listed.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Seung-Whan Lee, MD contact

82-10-7398-9897

seungwlee@amc.seoul.kr

16 sites in 1 country

South Korea16 sites, 16 recruiting

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si

    Yoon-Haeng Cho, MD

    Yoon-Haeng Cho, MD

    Recruiting

  • Gosin University Gospel Hospital

    Busan

    Jeong-Ho Heo, MD

    Jeong-Ho Heo, MD

    Recruiting

  • Inje University Pusan Paik Hospital

    Busan

    Tae-Hyun Yang, MD

    Tae-Hyun Yang, MD

    Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon

    Jae-Seok Bae, MD

    Jae-Seok Bae, MD

    Recruiting

  • Kangwon National University Hospital

    Chuncheon

    Bong-Ki Lee, MD

    Bong-Ki Lee, MD

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Cheol-Hyeon Lee, MD

    Cheol-Hyeon Lee, MD

    Recruiting

  • The Catholic university of korea, daejeon st. mary's hospital

    Daejeon

    Kyu-Sup Lee, MD

    Kyu-Sup Lee, MD

    Recruiting

  • Gangneung Asan Hospital

    Gangneung

    Han-Bit Park, MD

    Han-Bit Park, MD

    Recruiting

  • Jesushospital

    Jeonju

    Jong-Pil Park, MD

    Jong-Pil Park, MD

    Recruiting

  • Chungnam National University Sejong Hospital

    Sejong

    Jae-Hwan Lee, MD

    Jae-Hwan Lee, MD

    Recruiting

  • Seung-Whan Lee

    Seoul, 05505

    Seung-Whan Lee, MD, 82-10-7398-9897, seungwlee@amc.seoul.kr

    Recruiting

  • Kangbuk Samsung Medical Center

    Seoul

    Jong-Young Lee, MD

    Jong-Young Lee, MD

    Not yet recruiting

  • The Catholic university of korea, Eunpyeong st. mary's hospital

    Seoul

    Jung-hoon Lee, MD

    Jung-hoon Lee, MD

    Recruiting

  • Veterans Hospital Service Medical Center

    Seoul

    Chang-Hoon Lee, MD

    Chang-Hoon Lee, MD

    Recruiting

  • The Catholic University of Korea ST.VINCENT'S Hospital

    Suwon

    Sung-Ho Her, MD

    Sung-Ho Her, MD

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Gyung-Min Park, MD

    Gyung-Min Park, MD

    Recruiting

Other trials in South Korea

About this study

Official title: Influence of Novel Intravascular Ultrasound-Based Artificial Intelligence Technologies on Event Reduction Following Percutaneous Coronary Intervention (INNOVATE-PCI)

This study is a prospective, multicenter study in the real practice to validate the diagnostic performances and clinical impact of coronary angiography \& intravascular ultrasound (IVUS)-based models developed by machine learning (ML).

Read the detailed description

The aim of the study is to evaluate the performances and prognostic impact of coronary angiography \& IVUS-based algorithms for decision making and stent optimization in a multicenter, prospective cohort. Between January 2020 and June 2027, a total of 3,000 patients who performed coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea. In addition, the deferred lesions with visual estimated diameter stenosis of >30% will be evaluated as non-culprits. Brief study design is as depicted in the following figure.

Supervised ML algorithms include: 1) angiography- and IVUS-based algorithms for predicting FFR, 2) IVUS-based algorithm for plaque characterization, 3) IVUS-based algorithm for predicting stent expansion, and 4) post-stenting IVUS-based algorithm for predicting stent failure. In the prospective cohort, the performance of each model will be assessed. This registry trial composed of the treated (culprit) and the deferred (nonculprit) coronary lesions has two primary objectives as follow; 1) Primary objectives in treated (culprit) lesions is to see the impact of the integrated ML model on the development of culprit-related 2-year target vessel failure (TVF). 2) Primary objectives in deferred (nonculprit) lesions is to see the impact of the integrated ML model on the development of nonculprit-related 2-year TVF.

Being tested
percutaneous coronary intervention
Keywords
percutaneous coronary intervention, artificial intelligence, machine learning, intravascular ultrasound, coronary angiography
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • percutaneous coronary interventionProcedure or surgery

    IVUS-guided stent implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. culprit-related TVF

    composite of cardiac death, myocardial infarction (MI), stent thrombosis, and clinically-driven target vessel revascularization (TVR) at 2 years after SynergyTM implantation

    Measured: 2 years after stent implantation

  2. nonculprit-related TVF

    composite of cardiac death, MI, and clinically-driven TVR at 2 years

    Measured: 2 years after stent implantation

Secondary outcomes (5)

  1. each component of primary measures

    each of cardiac death, non-fetal MI, ST and target vessel revascularization

    Measured: 2 years after stent implantation

  2. all cause death

    all cause death

    Measured: 2 years after stent implantation

  3. repeat revascularization

    repeat revascularization

    Measured: 2 years after stent implantation

  4. stroke

    stroke

    Measured: 2 years after stent implantation

  5. bleeding

    bleeding

    Measured: 2 years after stent implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2023
  2. Study start20 Feb 2020
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05807841
Sponsor's protocol ID
2020-0226
Status last verified
Jun 2026
First submitted
29 Mar 2023
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Asan Medical Center at 16 sites in South Korea.

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 23 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in South Korea. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seung-Whan Lee, MD (82-10-7398-9897, seungwlee@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

culprit-related TVF (time frame: 2 years after stent implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05807841.

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 25 Jun 2026.

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