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

NCT05807841 | Recruiting

• 1 other identifier: 2020-0226
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 16

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).

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention; artificial intelligence; machine learning; intravascular ultrasound; coronary angiography

Outcome Measures

Primary Outcomes (2)

• 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

  2 years after stent implantation

• nonculprit-related TVF

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

  2 years after stent implantation

Secondary Outcomes (5)

• each component of primary measures

  2 years after stent implantation

• all cause death

  2 years after stent implantation

• repeat revascularization

  2 years after stent implantation

• stroke

  2 years after stent implantation

• bleeding

  2 years after stent implantation

Interventions

percutaneous coronary intervention PROCEDURE

IVUS-guided stent implantation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between February 2020 and June 2025, 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 15 centers in South Korea.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Boston Scientific Corporation: collaborator

Study Sites (16)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

RECRUITING

Gosin University Gospel Hospital

Busan, South Korea

RECRUITING

Inje University Pusan Paik Hospital

Busan, South Korea

RECRUITING

Gyeongsang National University Changwon Hospital

Changwon, South Korea

RECRUITING

Kangwon National University Hospital

Chuncheon, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

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

Daejeon, South Korea

RECRUITING

Gangneung Asan Hospital

Gangneung, South Korea

RECRUITING

Jesushospital

Jeonju, South Korea

RECRUITING

Chungnam National University Sejong Hospital

Sejong, South Korea

RECRUITING

Seung-Whan Lee

Seoul, 05505, South Korea

RECRUITING

Kangbuk Samsung Medical Center

Seoul, South Korea

NOT YET RECRUITING

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

Seoul, South Korea

RECRUITING

Veterans Hospital Service Medical Center

Seoul, South Korea

RECRUITING

The Catholic University of Korea ST.VINCENT'S Hospital

Suwon, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Seung-Whan Lee, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Whan Lee, MD

CONTACT

82-10-7398-9897; seungwlee@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: February 20, 2020
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

KR (16)