Intravascular Ultrasound guidaNce versuS angIoGrapHy Guidance in Patients With ST-segment Elevation Myocardial Infarction

NCT07616024 | Not Yet Recruiting

• 2 other identifiers: B2025-555ChiCTR2600124260
• Study Type: interventional
• Target: 1,956
• Locations: 1 country
• Sites: 1

Brief Summary

STEMI represents the subtype of ACS with the worst prognosis, associated with high mortality and an elevated risk of complications. The use of IVI guidance holds the potential to reduce the incidence of MACE. In previous studies, there has been limited research on intravascular imaging in the context of primary revascularization procedures for STEMI, and no large-scale cohort study has compared the differences in clinical outcomes between IVI-guided and angiography-guided primary revascularization. Therefore, we conducted this large-scale randomized controlled trial to compare IVI-guided primary PCI versus coronary angiography-guided primary PCI in patients with STEMI.

Conditions

PCI; STEMI

Keywords

STEMI; PCI; IVUS

Outcome Measures

Primary Outcomes (1)

• Primary target vessel failure (TVF) rate

  defined as the composite endpoint of cardiac death, ischemia-driven target vessel revascularization, and target vessel-related myocardial infarction.

  1 year

Secondary Outcomes (6)

• Lesion success rate

  Perioperative

• Clinical success rate

  Pre-discharge

• Mortality rate

  1 Year

• Incidence of myocardial infarction

  1 year

• Revascularization

  1 year

Study Arms (2)

IVUS group

EXPERIMENTAL

In the experimental group, after the guidewire passes through the lesion, IVUS is used to guide the primary PCI procedure.

Procedure: Intravascular Ultrasound

CAG group

OTHER

In the control group, after the guidewire passes through the lesion, coronary angiography is used to guide the primary PCI procedure

Procedure: Coronary angiography guidance

Interventions

Intravascular Ultrasound PROCEDURE

a catheter equipped with an ultrasound transducer is advanced over a guidewire into the vessel lumen distal to the target coronary lesion. Then, while slowly withdrawing the catheter, 360-degree cross-sectional images of the vessel are acquired to accurately measure lumen dimensions, assess plaque characteristics, select an appropriately sized stent, and confirm that after stent implantation the stent is fully apposed, well expanded, and free of vascular complications.

Also known as: IVUS group

IVUS group

Coronary angiography guidance PROCEDURE

A catheter is inserted through a peripheral artery (e.g., femoral or radial artery) and advanced to the ostium of the coronary arteries under fluoroscopic guidance. Once positioned, contrast medium is injected while X-ray images are acquired to visualize the coronary artery lumen and detect any stenoses or occlusions.

Also known as: CAG group

CAG group

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) who have an indication for emergency interventional therapy;
• Subjects who are eligible to undergo primary percutaneous coronary intervention (PCI);
• Subjects or their authorized family members voluntarily agree to participate in the clinical trial and sign the written informed consent form;
• The IVUS catheter is expected to pass through the target lesion to complete the examination.

You may not qualify if:

• Patients with cardiogenic shock or severe heart failure (Killip class IV);
• Patients who have previously undergone coronary artery bypass grafting (CABG);
• Patients with coma or disturbance of consciousness;
• Patients who are expected to be intolerant to long-term antiplatelet therapy;
• Pregnant women;
• Life expectancy \< 1 year;
• Currently participating in another drug/device clinical trial and not having reached the primary endpoint;
• Poor compliance, expected to be unable to complete follow-up.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Ultrasonography, Interventional

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Junbo Ge, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenguang Li, Doctor

CONTACT

+8613816767665; li.chenguang@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)