This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the safety and efficacy of the coronary sinus balloon pump (manufactured by Shanghai MicroPort Rotapace Medical Technology Co., Ltd.) as an adjunctive therapy during percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). As a pivotal study, it aims to support the product registration application to the National Medical Products Administration (NMPA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
177
The coronary sinus balloon pump comprises a coronary sinus balloon pump catheter system and a coronary sinus balloon pump therapeutic device. This product is indicated for the treatment of ST-segment elevation myocardial infarction (STEMI) with or without coronary microvascular dysfunction (CMD), by intermittently occluding coronary sinus blood flow during percutaneous coronary intervention (PCI) procedures to reduce myocardial infarction size.
Minimally invasive procedures used to open clogged coronary arteries
Myocardial infarct size
Myocardial infarct size is measured by cardiac magnetic resonance (CMR) 5 days after the procedure, expressed as a percentage of left ventricular mass (%LV).
Time frame: 5 days after the procedure
Incidence of Major Adverse Events (MAE) (Experimental Group)
Major Adverse Events (MAE) include: All-cause death Myocardial infarction Target vessel revascularization Hospitalization for heart failure New onset or worsening heart failure Coronary sinus dissection or perforation requiring intervention or surgical repair Thrombosis or thromboembolism Stroke Major bleeding (BARC Type 3\~5) Ventricular tachycardia or ventricular fibrillation requiring defibrillation or cardioversion
Time frame: at 30 days post-procedure
Device Success Rate (Experimental Group)
Successful delivery and deployment of the device to the coronary sinus and completion of the intended procedure
Time frame: Immediately post-procedure
Procedure Success Rate (Experimental Group)
Achievement of PCI success based on device success, without the occurrence of any CSBP-related adverse events
Time frame: Immediately post-procedure
Coronary Sinus Pressure (Experimental Group)
Time frame: Immediately post-procedure
Change in ST-Segment Elevation
Change in ST-Segment Elevation \[Comparison between post-PCI ECG and baseline\]
Time frame: Immediately post-procedure
Incidence of Device-Related Procedural Complications (Experimental Group)
Kefei Do
CONTACT
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Procedural Complications are defined as: Access site complications (including access site bleeding of BARC Type 3-5, access site infection requiring oral or intravenous antibiotics, access site complication requiring surgical intervention), coronary sinus dissection or perforation requiring intervention or surgical repair, pericardial effusion or cardiac tamponade requiring intervention or surgical treatment, thrombosis or thromboembolism, and stroke. The relatedness of a procedural complication to the device must be adjudicated by the Clinical Events Committee (CEC).
Time frame: Immediately post-procedure
Death (cardiac, vascular, non-vascular)
Rate of death (cardiac, vascular, non-vascular), as adjudicated by the Clinical Events Committee (CEC)
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Rate of heart failure hospitalization
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of new-onset or worsening heart failure
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of myocardial infarction
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of revascularization (target lesion, target vessel, any coronary)
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of stent thrombosis
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of major bleeding events
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of stroke
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Severity of angina
Angina severity (classified according to the Canadian Cardiovascular Society Classification of Angina Pectoris) is assessed by the level of physical activity that triggers the chest pain. And the lower the level that triggers the chest pain, the more serious angina.
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Ventricular tachycardia or ventricular fibrillation requiring defibrillation or cardioversion
Ventricular tachycardia or ventricular fibrillation requiring defibrillation or cardioversion as adjudicated by the CEC
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
EQ-5D quality of life score
Changes in quality of life measured by EQ-5D (assessed by the following five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression) (scale of 0-100: higher score better)
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of adverse events and serious adverse events
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of device deficiencies (Experimental Group only)
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure