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

NCT07616024 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1956

Last updated 2026-05-29

No results posted yet for this study

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

  • STEMI
  • PCI

Interventions

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.

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.

Sponsors & Collaborators

  • Shanghai 10th People's Hospital

    collaborator OTHER
  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Junbo Ge, Doctor · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2032-12-31
Completion
2032-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07616024 on ClinicalTrials.gov