Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease

NCT07741721 | Not Yet Recruiting DMC

• 1 other identifier: CNUH-2026-258
• Study Type: interventional
• Target: 1,252
• Locations: 1 country
• Sites: 30

Brief Summary

This prospective, multicenter, open-label, superiority trial will enroll patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. Following successful percutaneous coronary intervention (PCI) of the infarct-related artery (IRA), patients who meet the eligibility criteria will be randomized in a 1:1 ratio to either in-hospital staged complete revascularization with PCI of non-IRA lesions performed on a separate day during hospitalization, at least 72 hours after PCI of the IRA, or out-of-hospital staged complete revascularization with PCI of non-IRA lesions performed after discharge between 15 and 45 days of randomization. In both groups, non-IRA lesions with 50-69% stenosis will be evaluated using FFR.

Conditions

Myocardial Infarction (MI)

Keywords

ST-segment myocardial infarction; Multivessel coronary artery disease; Complete revascularization; Timing

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization

  At 12 months after randomization

Secondary Outcomes (17)

• Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization

  At 1, 6, 24, 36, 48, and 60 months after randomization

• All-cause death

  At 1, 6, 12, 24, 36, 48, and 60 months after randomization

• Nonfatal myocardial infarction

  At 1, 6, 12, 24, 36, 48, and 60 months after randomization

• All unplanned revascularization

  At 1, 6, 12, 24, 36, 48, and 60 months after randomization

• Cardiac death

  At 1, 6, 12, 24, 36, 48, and 60 months after randomization

Study Arms (2)

In-hospital staged complete revascularization

EXPERIMENTAL

In the in-hospital staged complete revascularization group, PCI of non-IRA lesions will be performed on a separate day during the index hospitalization, at least 72 hours after PCI of the IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Procedure: In-hospital staged complete revascularization

Out-of-hospital staged complete revascularization

ACTIVE COMPARATOR

In the out-of-hospital staged complete revascularization group, PCI of non-IRA lesions will be performed after discharge and between 15 and 45 days of randomization. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Procedure: Out-of-hospital staged complete revascularization

Interventions

In-hospital staged complete revascularization PROCEDURE

PCI of non-IRA lesions will be performed on a separate day during the index hospitalization, at least 72 hours after PCI of the IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

In-hospital staged complete revascularization

Out-of-hospital staged complete revascularization PROCEDURE

PCI of non-IRA lesions will be performed after discharge and between 15 and 45 days of randomization. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Out-of-hospital staged complete revascularization

Eligibility Criteria

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

You may qualify if:

• Age ≥19 years
• ST-segment elevation myocardial infarction (STEMI): ST-segment elevation ≥ 0.1 mV in at least two contiguous leads, or New-onset left bundle branch block (LBBB)
• Primary PCI within 12 h after symptom development
• At least 1 non-infarct related artery (non-IRA) with diameter ≥ 2.5 mm and 50% stenosis by visual estimation

You may not qualify if:

• Cardiogenic shock at initial presentation or after infarct-related artery (IRA) treatment
• Thrombolysis in myocardial infarction flow at non-IRA ≤ 2
• Severe procedural complications during primary percutaneous coronary intervention that, in the judgement of the operator, preclude study enrollment
• Non-IRA lesion unsuitable for percutaneous coronary intervention (PCI) treatment that, in the judgement of the operator, preclude study enrollment
• Chronic total occlusion in a non-IRA
• History of anaphylaxis to contrast agent
• Pregnancy and lactation
• Life expectancy \< 1 year
• Severe valvular heart disease
• History of coronary artery bypass grafting (CABG) or planned CABG
• Fibrinolysis therapy prior to admission
• Severe asthma

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (30)

Bucheon Sejong Hospital

Bucheon-si, South Korea

Location

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Location

Samsung Changwon Medical Center

Changwon, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Yeongnam University Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Chosun University Hospital

Gwangju, South Korea

Location

Gwangju Veterans Hospital

Gwangju, South Korea

Location

Kwangju Christian Hospital

Gwangju, South Korea

Location

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, South Korea

Location

Jeju National University Hospital

Jeju City, South Korea

Location

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Presbyterian Medical Center

Jeonju, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Inje University Busan Paik Hospital

Pusan, South Korea

Location

Inje University Haeundae Paik Hospital

Pusan, South Korea

Location

Kosin University Gospel Hospital

Pusan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Koera University Guro Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Yonsei University Health System, Gangnam Severance Hospital

Seoul, South Korea

Location

St. Carollo General Hospital

Suncheon, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Youngkeun Ahn, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Chul Kim, MD, PhD

CONTACT

82-10-4606-2643; kmc3242@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): July 31, 2035
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (30)