About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Intravascular Ultrasound
Procedure/Surgerya 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
Procedure/SurgeryA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Lesion success rate
Lesion success assessed by coronary angiography and lesion success rate assessed by IVUS.
Clinical success rate
Lesion success assessed by coronary angiography and lesion success rate assessed by IVUS.
Mortality rate
Includes cardiovascular death, non-cardiovascular death, and death of undetermined cause
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)
Sponsors and contacts
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Shanghai Zhongshan Hospital
Lead sponsor
Shanghai 10th People's Hospital
Collaborator
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