NCT05807841 Clinical Impact of Intravascular Ultrasound-Based Artificial Intelligence Technologies (INNOVATE-PCI)
| NCT ID | NCT05807841 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asan Medical Center |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2020-02-20 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2020-02-20 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * 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
Contact & Investigator
Seung-Whan Lee, MD
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT05807841 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05807841 currently recruiting?
Yes, NCT05807841 is actively recruiting participants. Contact the research team at seungwlee@amc.seoul.kr for enrollment information.
Where is the NCT05807841 trial being conducted?
This trial is being conducted at Bucheon-si, South Korea, Busan, South Korea, Busan, South Korea, Changwon, South Korea and 11 additional locations.
Who is sponsoring the NCT05807841 clinical trial?
NCT05807841 is sponsored by Asan Medical Center. The principal investigator is Seung-Whan Lee, MD at Asan Medical Center. The trial plans to enroll 3,000 participants.