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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorAsan Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

ST-segment elevation MI at admission

Patients who underwent coronary artery bypass surgery or heart transplantation

Left ventricular ejection fraction <30%

Cardiogenic shock

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • percutaneous coronary intervention

    Procedure/Surgery

    IVUS-guided stent implantation

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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

Time frame
2 years after stent implantation
2

nonculprit-related TVF

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

Time frame
2 years after stent implantation

Secondary outcomes

1

each component of primary measures

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

Time frame
2 years after stent implantation
2

all cause death

all cause death

Time frame
2 years after stent implantation
3

repeat revascularization

repeat revascularization

Time frame
2 years after stent implantation
4

stroke

stroke

Time frame
2 years after stent implantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

Boston Scientific Corporation

Collaborator