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.
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 2488 subjects, with 1244 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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,488
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.
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.
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
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.
Time frame: 1 year
Lesion success rate
Lesion success assessed by coronary angiography and lesion success rate assessed by IVUS.
Time frame: Perioperative
Clinical success rate
Lesion success assessed by coronary angiography and lesion success rate assessed by IVUS.
Time frame: Pre-discharge
Mortality rate
Includes cardiovascular death, non-cardiovascular death, and death of undetermined cause
Time frame: 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)
Time frame: 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
Time frame: 1 year
Stent thrombosis
Academic Research Consortium
Time frame: 1 year
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