Intravascular Ultrasound guidaNce versuS angIoGrapHy Guidance in Patients With ST-segment Elevation Myocardial Infarction (INSIGHT-STEMI)

Intravascular Ultrasound guidaNce versuS angIoGrapHy Guidance in Primary percuTaneous Coronary Intervention for Patients With ST-segment Elevation Myocardial Infarction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: STEMI; PCI
• Intervention / Treatment: Procedure: Intravascular Ultrasound; Procedure: Coronary angiography guidance

Detailed Description

This study is a prospective, multicenter, randomized controlled, superiority clinical trial. Eligible subjects who meet the inclusion/exclusion criteria will be randomly assigned in a 1:1 ratio to either the IVUS-guided strategy (experimental group) or the conventional coronary angiography-guided strategy (control group). The study plans to enroll at least 1,956 subjects, with 978 subjects in each of the experimental and control groups. Zhongshan Hospital, Fudan University serves as the lead center. A competitive enrollment approach will be adopted, with the number of cases enrolled by the lead center not exceeding 50% of the total sample size.

In the IVUS group, intravascular ultrasound (IVUS) will be used for guidance; the use of high-frequency intravascular ultrasound (resolution ≥ 50 MHz) is encouraged, though not mandatory.

• Study Type: Interventional
• Enrollment (Estimated): 1956
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chenguang Li, Doctor; Phone Number: +8613816767665; Email: li.chenguang@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital
      • Principal Investigator: Junbo Ge, Doctor
      • Contact: Chenguang Li, Doctor; Phone Number: +8613816767665; Email: li.chenguang@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

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

Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVUS group; In the experimental group, after the guidewire passes through the lesion, IVUS is used to guide the primary PCI procedure.	Procedure: Intravascular Ultrasound; 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.; Other Names: IVUS group
Other: CAG group; 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; 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.; Other Names: CAG group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion success rate	Lesion success assessed by coronary angiography and lesion success rate assessed by IVUS.	Perioperative
Clinical success rate	Lesion success assessed by coronary angiography and lesion success rate assessed by IVUS.	Pre-discharge
Mortality rate	Includes cardiovascular death, non-cardiovascular death, and death of undetermined cause	1 Year
Incidence of myocardial infarction	includes periprocedural myocardial infarction as defined by SCAI and spontaneous myocardial infarction (infarct-related artery-related vs. non-infarct-related artery-related; culprit lesion-related vs. non-culprit lesion-related)	1 year
Revascularization	includes ischemia-driven and non-ischemia-driven revascularization, revascularization of infarct-related and non-infarct-related arteries, revascularization of culprit and non-culprit lesions, revascularization of target vessels and non-target vessels, and revascularization of target lesions and non-target lesions	1 year
Stent thrombosis	Academic Research Consortium	1 year

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Junbo Ge, Doctor, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PCI; STEMI; IVUS
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Imaging; Ultrasonography; Ultrasonography, Interventional
• Other Study ID Numbers: B2025-555; ChiCTR2600124260 (Other Identifier: Chinese Clinical Trail Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No