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Clinical Trials in China / NCT07616024
Starting soon Not applicable

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

NCT07616024 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Not applicable
Started
2026-06-01
Last updated
2026-06-18

Condition(s) studied

STEMIPCI

Investigational drug(s) / intervention(s)

Intravascular UltrasoundCoronary angiography guidance

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.

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital Shanghai Shanghai Municipality

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07616024 on ClinicalTrials.gov ↗ ← All trials in China