NCT05807841Recruiting
Clinical Impact of Intravascular Ultrasound-Based Artificial Intelligence Technologies (INNOVATE-PCI)
Influence of Novel Intravascular Ultrasound-Based Artificial Intelligence Technologies on Event Reduction Following Percutaneous Coronary Intervention (INNOVATE-PCI)
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 29 Mar 2023
- Start date
- 20 Feb 2020
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Asan Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT05807841
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 20 Feb 2020 to the primary completion date, 31 Dec 2028
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soon Chun Hyang University Hospital Bucheon Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Recruiting |
| Inje university Pusan Paik hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Gosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Gyeongsang National University Changwon hospital Coordinator of this site? Confirm its status | Changwon | South Korea | Recruiting |
| Kangwon National University Hospital Coordinator of this site? Confirm its status | Chuncheon | South Korea | Recruiting |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| The Catholic University of Korea, Daejeon ST.Mary's Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
| Gangneung Asan Hospital Coordinator of this site? Confirm its status | Gangneung | South Korea | Recruiting |
| Jesushospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Recruiting |
| Chungnam National University Sejong Hospital Coordinator of this site? Confirm its status | Sejong | South Korea | Recruiting |
| Seung-Whan Lee Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kangbuk Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Veterans Hospital Service Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.